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

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%)....

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 eye, they are easily affected by the subjective judgment of the observer, the sensitivity is low, and the accuracy of the results is not high. Moreover, the detection of P24 antigen cannot be used, and the detection window period is relatively long.

[0006] Western blotting (WB) is the current confirmation method for clinical AIDS detection. The result is accurate and reliable, but its technology is difficult. At present, there are only a handful of companies in the world that can produce it. The high cost of use makes it currently only used for Confirmation of suspicious specimens, rarely used for screening

[0007] Both the cell culture method and the PCR method require high experimental working environment and conditions (sterile operation room, ultra-clean workbench) and a large number of instruments and equipment (incubator, centrifuge, PCR instrument, etc.), and the operation is extremely complicated. It needs to be operated by strictly professionally trained personnel, and the test period is very long, so it is not suitable for clinical testing

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