Magnetic immunochromatographic test strip for combined detection of HIV-1+2 antibody and P24 antigen and preparation method thereof

A magnetic immunochromatography and combined detection technology, applied in the field of medical testing, can solve the problems of long reaction time, long test period, limited application, etc., and achieve the effects of simplifying the preparation process, shortening the window period, and reducing subjectivity.

Inactive Publication Date: 2009-10-28
CHEMCLIN DIAGNOSTICS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] ELISA is currently the most commonly used detection technology in clinical blood screening. The third-generation reagents are used to detect virus antibodies. The fourth-generation reagents appeared in the late 1990s. They detect P24 antigens at the same time on the basis of detecting antibodies, but the ELISA test procedure is complicated. , prone to false positive or false negative results, and low sensitivity, CLIA is similar to ELISA method, but the sensitivity is improved a little, and the problems existing in ELISA are not fundamentally solved, and both of them have the problems of cumbersome operation and long reaction time, and Both require complex equipment such as microplate readers or luminometers, plate washers, and incubators, and cannot be tested by a single person, which further limits their application in some grassroots hospitals and clinics.
In recent years, rapid detection test strips represented by colloidal gold or latex particles have appeared at home and abroad, but because the results are visually observed by the naked

Method used

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  • Magnetic immunochromatographic test strip for combined detection of HIV-1+2 antibody and P24 antigen and preparation method thereof

Examples

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Embodiment 1

[0039] Preparation method of magnetic immunochromatography test strip and test kit for combined detection of HIV-1+2 antibody and P24 antigen in blood

[0040] The preparation method of test strip and test paper box of the present embodiment comprises the following steps:

[0041] A. Preparation of antigen and antibody: select commercialized HIV1+2 recombinant antigen and P24 monoclonal antibody, dialyze against 20mM PBS with pH7.2 (pH7.0-7.6 is applicable), and dialyze overnight at 4°C for future use.

[0042] B. Preparation of coating film:

[0043] Coating buffer preparation: 0.02M phosphate buffer solution (PBS) with pH 7.2 was used as the coating buffer, which was sterilized by 0.22 μm microporous membrane and stored at 4°C for later use, with a validity period of two weeks.

[0044] Preparation of blocking solution: 0.02M phosphate buffered saline (PBS) containing 0.5% BSA at pH7.2 (pH7.0-7.6 is applicable), 0.22μm microporous membrane filter and sterilize, and store at...

Embodiment 2

[0072] Except; in the step of preparation of streptavidinized magnetic particles: streptavidin so that the ratio of streptavidin to magnetic particles is 1:2. Other steps are with embodiment 1,

Embodiment 3

[0074] In addition to the step of preparation of streptavidinized magnetic particles: streptavidin so that the ratio of streptavidin to magnetic particles is 1:10. Other steps are the same as in Example 1.

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Abstract

The invention relates to a magnetic immunochromatographic test strip for combined detection of HIV-1+2 antibody and P24 antigen and a preparation method thereof. The test strip is assembled by pasting a coating film, magnetic particles combined with the HIV-1+2 antibody and the P24 antigen, a sample pad and a water-absorbing pad which are mutually staggered by 2 millimeters in turn on a bottom plate and then covering an upper layer with a transparent plastic sealing film, wherein the coated film is precoated with an HIV-1+2 antibody detection line, an HIV P24 antigen detection line and a quality control line. As the test strip introduces a magnetic immunochromatography technique and a biotin-avidin system into the combined detection of the HIV-1+2 antibody and the P24 antigen, the test strip has the advantages of greatly increasing detection sensitivity result accuracy, shortening detection window period and reducing the labor intensity of operators.

Description

technical field [0001] The invention belongs to the field of medical testing, in particular to a magnetic immunochromatographic test strip for combined detection of HIV-1+2 antibody and P24 antigen and a preparation method thereof. Background technique [0002] AIDS, or Acquired Immure Deficiency Syndrome (AIDS), is caused by human immunodeficiency virus (human immunodeficiency virus, HIV). The United Nations Program on AIDS and the World Health Organization jointly released a report stating that in 2006, the number of people living with HIV worldwide was 39.5 million; in 2006, there were 4.3 million new HIV infections; in 2006, 2.9 million people died of AIDS worldwide. According to the "Joint Assessment Report on AIDS Prevention and Control in China (2007)" issued by the Ministry of Health of China, by the end of 2007, there were about 700,000 (550,000-850,000) HIV-infected people and patients in my country, and the infection rate of the whole population was 0.05% (0.04%)....

Claims

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Application Information

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IPC IPC(8): G01N33/558
Inventor 姚洪涛应希堂宋胜利胡国茂郑金来唐宝军于尚永
Owner CHEMCLIN DIAGNOSTICS CO LTD
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