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HIV-1/2 Antibody/p24 Antigen Test Kit (LFIA)
● Detection time: 20-30 minutes
● Storage: Room temperature (2-30°C)
● Shelf life: 24 months
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Intended Use
HIV-1/2 Antibody/p24 Antigen Test Kit (LFIA) is suitable for in vitro qualitative detection of Human Immunodeficiency Virus Type 1 (HIV-1) p24 antigen (Ag) and antibodies (Ab) to HIV Type 1 and Type 2 (HIV-1 and HIV-2) in human serum, plasma, capillary (fingerstick) whole blood or venipuncture (venous) whole blood.
Summary
Human immunodeficiency virus, also known as HIV, is a retrovirus that causes human immune system defects. Human immunode- ficiency virus can be divided into HIV Type 1 and HIV Type 2. After human infection with HIV, HIV RNA begins to appear in body fluids of infected people, and then antigen appears.The immune system begins to produce corresponding antibodies after antigen appears. The window period of IgM is shorter than that of IgG, IgM only exists for a short time, while IgG remains positive for a long time. During the window period, the body fluid has been infected, and the antibody will form a complex with the antigen, making it difficult to detect the antigen.
Test Principle
This HIV-1/2 Antibody/p24 Antigen Test Kit (LFIA) is based on immunochromatographic technology to simultaneous and separate qualitative detection of free HIV-1 p24 antigen and antibodies to HIV-1 and HIV-2. Test cassette: 1)Colloidal gold-labeled HIV-1 and HIV-2 recombinant antigen, anti-HIV-1 p24 antibody and chicken IgY antibody ;2)One Ag detection line , One Ab detection line and one quality control C line fixed on a nitrocellulose membrane.The Ag line is fixed with anti-HIV-1 p24 antibody to detect free HIV-1 p24 antigen.The Ab line is fixed with HIV-1 and HIV-2 recombinant antigen to detect antibodies to HIV-1 and HIV-2.The quality control antibody is fixed on the C line.
When an appropriate amount of the sample to be tested is added to the sample well of the test cassette, the sample will move forward along the test strip under capillary action.
If the sample contains HIV-1 p24 antigen, the antigen bind to the colloidal gold-labeled anti-HIV-1 p24 antibody from the conjugate pad. When the anti-HIV-1 p24 antibody is combined, the immune complex will be captured by the anti-HIV-1 p24 antibody immobilized on the membrane to form a red Ag line. The result is positive for the HIV-1 p24 antigen. If the Ag detection line does not show color, the result is negative.
If the sample contains antibodies to HIV-1 and/or HIV-2 , the antibodies bind to colloidal gold-labeled recombinant gp41 (HIV-1) and gp36 (HIV-2) antigen from the conjugate pad.When the recombinant gp41 (HIV-1) and gp36 (HIV-2) antigen is combined, the immune complex will be captured by the recombinant gp41 (HIV-1) and gp36 (HIV-2) antigen immobilized on the membrane to form a red Ab line. The result is positive for the antibodies to HIV-1 and/or HIV-2 . If the Ab detection line does not show color, the result is negative.
Warnings and Precautions
• For human in vitro clinical diagnostics only.
• The product should only be used by healthcare professionals or trained technicians.
• The product should be used within 1 hour after opening the package. The test cassette should not be used if being wet or polluted.
• Do not freeze test cassette or buffer solution.
• Dispose of all used or damaged test cassettes, lancet, buffer solution bottle or other kit components as biohazardous materials.
• Handle specimens in accordance to the OSHA Standard on Bloodborne Pathogens.
• Wear protective gloves,clothing,and eyewear.
• Wash hands thoroughly after handling specimens.
• Do not use test cassette, buffer solution, or any other kit components if the pouch is damaged or the seal is broken.
• Do not use samples containing lipids, hemolysis, or turbidity which can affect results.
• Not for use with heat inactivated or other inactivated human specimen (blood, serum, plasma).
• This package the insert must be read completely before performing the test. Failure to follow directions in insert may yield inaccurate test results.
• Test results should be read between 20 and 30 minutes after a specimen is applied to the sample well. Results read after 30 minutes may give erroneous results.
• Do not use test cassette, buffer solution or any kit components beyond the indicated expiration date.
关键词:
STD
HIV
TEST KIT
human immunodeficiency virus
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