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HIV antibody and antigen combined rapid detection reagent kit

A technology for human immunodeficiency and detection kits, which can be used in measurement devices, instruments, scientific instruments, etc., can solve problems such as incompatibility with rapid diagnostic reagents, and achieve the effect of shortening the window period, improving the detection rate, and good stability.

Active Publication Date: 2013-05-29
天津中新科炬生物制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although Xu Keyi and others published "Development of rapid diagnostic reagents for simultaneous detection of HIV antibody and p24 antigen" [Xu ​​Keyi, Zhang Yongxin, Wang Ying, etc., Development of rapid diagnostic reagents for simultaneous detection of HIV antibody and p24 antigen, Chinese Journal of Experimental and Clinical Virology, 2002 , 16(4)377-279], but it is not an immunochromatographic method, the actual method is similar to the ELISA detection method, the whole detection process is divided into multiple steps, and the detection time exceeds 1 hour, which does not meet the standards of rapid diagnostic reagents

Method used

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  • HIV antibody and antigen combined rapid detection reagent kit
  • HIV antibody and antigen combined rapid detection reagent kit
  • HIV antibody and antigen combined rapid detection reagent kit

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1HI

[0047] The preparation of embodiment 1 HIV antibody and antigen joint rapid detection test paper A9, test paper B10:

[0048] 1 main material

[0049] 1.1 Recombinant antigens: HIV gp41, gp36: American Biotech Atlantic Inc (BAI.) products, used for coating and labeling of test paper A; anti-HIV P24 antibody pairing: products of BAI Company, used for coating and labeling of test paper B; Auric acid: product of Sigma company, NC membrane: product of Millipore company; BSA, PEG 20000, hydrolyzed casein: product of Sigma company. Other commonly used reagents are analytical reagents. 1.2 HIV antibody national reference product (colloidal gold): developed by China Institute for the Control of Pharmaceutical and Biological Products. Including 20 positive sera, 20 negative sera, 3 sensitivity sera, and 1 precision sera. National reference materials for HIV1 P24 antigen, including 10 positive sera, 20 negative sera, 10 sensitivity sera, and 2 precision sera.

[0050] 2 methods

[...

Embodiment 2

[0058] Example 2: Performance Analysis of HIV Antibody Antigen Combined Rapid Diagnostic Kit

[0059] 1 main material

[0060] 1.1 HIV Antibody Antigen Combined Rapid Diagnostic Kit: See Example 1 for the preparation method;

[0061] 1.2 National reference materials for HIV antibody and antigen: inspected and developed by China National Institute for the Control of Pharmaceutical and Biological Products, see Example 1 for description;

[0062] 1.3 Serum containing interfering substances: including 10 serums of common interfering substances hyperlipidemia, hemolysis, and jaundice, 10 serums containing positive antibodies to related infectious diseases HAV, HBV, HIV, TP, and HP, and containing different anticoagulants heparin, EDTA, and 10 copies of sodium citrate plasma were collected and verified by our company in relevant hospitals in Tianjin and stored. The above serum or plasma were tested by two or more ELISAs and all were HIV antibody and antigen negative serum.

[0063...

Embodiment 3

[0082] Example 3: Preparation of HIV Antibody and Antigen Combined Rapid Kit 18:

[0083] image 3 Front view of the cover of HIV Antibody and Antigen Combined Rapid Test Kit. Figure 4 Rear view of the lid of the HIV Antibody and Antigen Combined Rapid Test Kit. Figure 5 Bottom view of HIV Antibody and Antigen Combined Rapid Detection Kit. Such as image 3 , Figure 4 , Figure 5 Shown, human immunodeficiency virus (HIV) antibody and antigen combined rapid kit 18 are made of box cover 19, box bottom 31, box cover 19, box bottom 31 all are to adopt plastic injection molding to form integrally, box cover 19, box bottom The bottom 31 is two rectangular box-shaped bodies.

[0084] The length, width and height of the lid 19 are set with the length, width and height of the test paper A9 and the test paper B10, and two rectangular holes of the same size are set on the front left side of the lid 19 as the B reaction zone hole 23 and the A reaction zone Hole 24, on the right s...

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Abstract

The invention relates to biology applied technology field, especially relates to a immune chromatography assay for quickly detecting the human immunologic deficiency disease (HIV) antibody and antigen. The assay comprises two independent test papers A and B and plastic case C for storing the test paper, wherein the test paper A is used for detecting the HIV antibody and the test paper B is used for detecting the HIV p24 antigen. The test paper A and test paper B are parallely encased in the plastic case to constitute the assay. On detecting, the detected sample is added on the sample pad of the test paler and the immunoreaction result is directly observed to perform detection. The assay is used for screening or clinical diagnosis of the HIV infection and at the same time the HIV antigen and antibody are detected, the simpler antibody detection can effectively reduce the window phase for detecting the HIV, with features of quick reaction, easy operation, economy and practicality, suitable for insitu detecting.

Description

technical field [0001] The invention relates to the technical field of biological applications, in particular to an immunochromatographic kit for combined rapid detection of HIV antibodies and antigens. Background technique [0002] Acquired Immunodeficiency Syndrome (AIDS), referred to as AIDS, is a serious infectious disease caused by human immunodeficiency virus (Human immunodeficiency virus, HIV) infection. Since the first AIDS patient was diagnosed in the United States in 1981, according to the latest WHO data, by the end of 2007, there were estimated to be 33 million HIV-infected people in the world, and there were about 700,000 HIV-infected people in China. [0003] HIV transmission routes mainly include blood transmission, sexual contact, drug injection and mother-to-child transmission. The average incubation period in the human body is 7 to 10 years. Patients in the latent period of HIV infection have no obvious clinical symptoms, but are highly contagious. Detec...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/569G01N33/558G01N33/532
Inventor 李洲杨发青
Owner 天津中新科炬生物制药股份有限公司
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