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The INSTI HIV Self Test is an immunoassay for detecting HIV antibodies. The test is intended for use by untrained lay users as a self test to aid in the diagnosis of HIV-1 and HIV-2 infection using a small drop (50μL) of blood obtained through fingerstick collection procedures.
The INSTI HIV Self Test is an immunoassay for detecting HIV antibodies. The test device consists of a synthetic membrane positioned atop an absorbent pad within a plastic cartridge. One section of the membrane has been treated with non-hazardous HIV-1 and HIV-2 recombinant proteins, which capture HIV antibodies (test dot). The membrane also includes a control dot treated with protein-A that captures other non-specific antibodies normally present in human blood. The test is performed by adding a fingerstick blood sample to Bottle 1. The diluted blood in Bottle 1 is poured into the well of the test device. Any HIV antibodies in the sample are captured by the test dot and non-specific antibodies are captured by the control dot. Bottle 2 is then added to the test device. Bottle 2 solution reacts with captured antibodies to produce a blue dot at control dot and, if HIV antibodies are present, a blue dot also appears at test dot. In the final step, Bottle 3 is added to the membrane to make the control and test dots more visible.

How early can this test detect HIV?
Based on bioLytical's studies, INSTI demonstrates third generation performance and detects HIV antibodies of the IgM and IgG class. IgM antibodies are the earliest antibodies that the body produces after an HIV infection and are detectable within 21-22 days.1,2 Depending on how quickly a person’s immune system generates HIV antibodies after infection, it could still take up to 3 months to get a positive result.

If you think you have been exposed to HIV within the last 3 months, and your results are negative, you will need to test again after at least 3 months have passed since your exposure. The time from HIV infection to when a test can correctly give a positive result is referred to as the ‘window period’.

About HIV:
HIV stands for Human Immunodeficiency Virus. HIV is the virus that causes AIDS (Acquired Immunodeficiency Syndrome) if left untreated. It is estimated that there are over 30 million people living with HIV in the world today, and up to half of those people have not been diagnosed and are unaware of their infection. This undiagnosed population accounts for most of the HIV transmissions worldwide. Treatment for HIV is highly effective. It is important to start treatment as early as possible following infection, to reduce the risk of serious illness or death.

Test Contents:
Instructions for Use
Pouch with test device (labelled Membrane Unit)
Sample Diluent (Bottle 1, red top)
Colour Developer (Bottle 2, blue top)
Clarifying Solution (Bottle 3, clear top)
Sterile single-use lancet
Adhesive bandage
Resources Card