HIV (human immunodeficiency virus) is a virus that attacks the immune system, the body's defense against illness. If left untreated, HIV can lead to AIDS (acquired immunodeficiency syndrome). HIV and AIDS can't be cured, but the medications available today help people live normal life spans.
HIV spreads through contact with blood, semen, pre-seminal fluid, rectal fluid, vaginal fluids, or breast milk of an infected person. Transmission can occur from unsafe sex. It can also result from exposure to blood through the sharing of used syringes or needles. Women living with HIV can pass the virus to their babies during pregnancy, childbirth, and breastfeeding. It is also possible to become infected with HIV through a blood transfusion, although this is now very rare. HIV cannot be passed on from one person to another through casual contact. There is no risk of infection when we share everyday items such as food, dishes, utensils, clothes, beds and toilets with a person living with HIV. The virus is not spread from contact with sweat, tears, saliva, or a casual kiss from an infected person. People do not become infected from eating food prepared by a person living with HIV. People have not become infected with HIV through insect bites.
The test uses simple flow-through technology to detect HIV-1 and HIV-2 antibodies using a drop of human fingerstick blood. The test does not detect the virus itself. The test dot will only be visible if HIV antibodies are present. The INSTI HIV Self Test is simple to perform and very accurate, but it will only work correctly if you carefully read and follow the instructions. You may test positive with INSTI HIV Self Test in as little as 21-22 days after infection(1), however, it can take as long as 3 months to produce a positive result. A negative result may not be accurate until 3 months after infection. (1) Moshgabadi N, Galli RA, Daly AC, Ko SM, Westgard TE, Bulpitt AF, Shackleton CR., 2015. “Sensitivity of a rapid point of care assay or early HIV antibody detection is enhanced by its ability to detect HIV gp41 IgM antibodies.” J Clin Virol. 2015 Oct;71:67-72.
Antibodies are produced by your body’s immune system in response to pathogens. Their purpose is to defend us against infection.
Extensive research studies have shown that this test is extremely accurate when performed correctly. In a recent study performed by untrained users, the test sensitivity was 100%. It also has a proven specificity (a measure of reliability that the test will be negative for people who do not have HIV infection) of 99.5%. In the untrained user study, the specificity was 99.8%. *If you are unsure of your result you must go to a doctor to perform more testing.
This is the time from the HIV infection to when a test can correctly give a positive result. You may test positive with INSTI HIV Self Test in as little as 21-22 days after infection(1), however it can take as long as 3 months to produce a positive result. A negative result may not be accurate until 3 months after the infection. If you think you have been exposed to HIV within the last 3 months, and your results are negative, you should test again after at least 3 months have passed since your exposure. (1) Moshgabadi N, Galli RA, Daly AC, Ko SM, Westgard TE, Bulpitt AF, Shackleton CR., 2015. “Sensitivity of a rapid point of care assay or early HIV antibody detection is enhanced by its ability to detect HIV gp41 IgM antibodies.” J Clin Virol. 2015 Oct;71:67-72.
The INSTI HIV Self Test has a built-in control dot to show that the test has been performed correctly and that you have added the proper amount of fingerstick blood. If the control dot does not appear, your test has not worked. Please discard your test and retest with a new test. If only the control dot is visible it means that your result is negative and you probably do not have HIV. If two dots are visible your test result is positive. This means you likely have HIV. Although the results of the INSTI HIV Self Test are very accurate, you MUST have a positive result confirmed by a doctor as soon as possible so that treatment can be started immediately. It is essential for your health and wellbeing that you seek medical advice if your result is positive.
Continue to make efforts to stay negative by reducing risks of exposure to HIV, such as practicing safer sex and other prevention methods. If you believe that you have been exposed in the past 3 months, repeat testing after 3 months. It is recommended to test every 3-12 months if you are high risk to acquiring HIV.
Go to your doctor or nearest testing facility to receive confirmatory testing. Remember that any HIV self test is a screening test only and is not a conclusive diagnosis.
Visit your doctor or nearest testing facility for further testing.
You might feel a slight pinch. It does not matter which finger you use, the blood will be the same.
As long as the control dot shows a visible dot after pouring Bottle 3 into the membrane unit, the test results are valid.
Make sure you have adequate lighting. If no dots are visible, you may not have completed the test correctly, or collected enough blood. You will need to do another test.
It is very rare for this to happen, but if it does, you will not be able to complete the test procedure and read the results. You will need to perform another test.
Relax and have a drink of water about 20 minutes before you start the test. Warm your hands by washing them with warm water. Ensure your hands are dry. Place your hand below waist level to promote blood flow. Before using the lancet, look for a spot on the side of your finger tip that is smooth and not calloused and away from your fingernail.
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’. (1)Moshgabadi N, Galli RA, Daly AC, Ko SM, Westgard TE, Bulpitt AF, Shackleton CR., 2015. “Sensitivity of a rapid point of care assay for early HIV antibody detection is enhanced by its ability to detect HIV gp41 IgM antibodies.” J Clin Virol. 2015 Oct; 71:67-72. (2)M. Cohen, C. Gay, M. Busch, F. Hecht, The detection of acute HIV infection, J.Infect. Dis. 202 (2010) 270–277.
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