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Human immunodeficiency virus, also known as HIV. AIDS refers to the destruction of the body's immune system by HIV, which causes the body to lose its resistance to various pathogens that threaten life, resulting in a variety of infections or tumors, leading to a serious infectious disease. It is mainly transmitted through blood, sexual contact, and mother-to-child transmission.
At present, the diagnosis of HIV mainly relies on the detection of blood HIV antibodies. However, due to the invasive of blood collection and the risk of infection with blood-borne infectious diseases, it is increasingly recognized that the ideal HIV detection method should be non-invasive, safe, and sensitive. HIV antibodies are present in blood, oral mucosal transudate, urine, tears, semen
and vaginal secretions in the body, and it has been reported in the literature that the sensitivity and specificity of HIV antibody detection by oral mucosal exudate can reach 99.9%. When the oral mucosal transudate is used as a sample, it has the characteristics of simple operation, no pain, easier sampling, safer handling of biological waste, and no high-risk behaviors such as needle sticks.This reagent is suitable for auxiliary diagnosis of human
immunodeficiency virus infection.
Test Principle
The reagent uses the principle of gold-labeled immunochromatographic
method to detect HIV-1 and HIV-2 antibodies in oral mucosal transudate. The test region is coated with HIV-1 antigen and HIV-2 antigen ,the control region is coated with goat anti-rabbit IgG antibody.
When the sample contains HIV-1 and HIV-2 antibodies and the concentration is equal to or higher than the limit of detection, the antibody will form an "antibody-gold-labeled antigen complex" with the labeled protein A, and move forward, it is captured by the HIV-1 antigen and HIV-2 antigen pre-coated on the nitrocellulose membrane, forming a reaction line(T line), and the result is positive, when the sample does not contain HIV-1 and HIV-2 antibodies or the concentration is lower than the limit of detection , the test line does not appear, and the result is negative. Regardless of whether the sample contains HIV-1 and HIV-2 antibodies, the labeled rabbit IgG will be captured by the goat anti-rabbit IgG antibody coated on the nitrocellulose membrane, that is, the control line (C line) will form a reaction line.
Test Procedure
Instruction for use must be read entirely before taking the test. Allow the reagent to equilibrate to room temperature for 30 minutes (10-30°C) prior to testing. Do not open the inner packaging until ready, it must be used in one hour if opened (Humidity≤60%, Temp: 10-30°C). Please use immediately when the humidity exceed to 60%.
Remove the cassette from the sealed pouch
Add 3 drops (approximately 80μL) sample vertically to the sample well with a disposable plastic straw, and the timer starts
Read the result in 15-30 minutes, the result is invalid after 30 minutes
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