HIV self-testing Description Screening test for HIV (the virus that causes AIDS) performed on a blood sample taken from the fingertip. This is a reliable self-test for diagnosing HIV infections that occurred at least three months ago. Autotest VIH is a single-use in vitro diagnostic device. HIV self-testing can be performed by non-experts in a private setting. The test takes approximately 5 minutes, and the waiting time until the result is read is 15 minutes. You must have a watch or other timekeeping device. How to use 1. Place the test tube holder on a flat surface. Gently pull the lid containing the buffer solution to separate it from the self-test. Use your finger to slide it to the bottom of the test tube holder. 2. Wash your hands, preferably with warm water, and dry them. Open the pouches containing the disinfectant wipe and sterile tablet. Rub the disinfectant wipe onto your fingertip and allow to dry. Remove the cap from the safety scalpel. Place the red tip of the scalpel on your fingertip and press down firmly to pierce the skin with the needle. Gently squeeze your finger to form a first large drop of blood. Remove the drop with a sterile gauze pad. Without applying too much pressure, gently squeeze your finger again to form another large drop of blood. With the self-test pointing downwards, touch the tip of the device to the blood drop until the tip fills with blood. 3. Make sure the test tube holder containing the buffer cap is placed on a flat surface. Hold the test strip with the tip pointing down and insert it firmly into the test tube holder, piercing the aluminum membrane of the buffer cap. Press firmly (you will hear a three-click sound). Look for a pink spot, which should begin to appear within one minute of inserting the test device and swab cap. Apply the patch to your finger. 4. Check the time and wait 15 minutes before reading the result. Non-reactive self-test: one line appears: control line (HIV negative). Reactive self-test: two lines appear: the control line and the test line (probably HIV positive). If positive: - contact a doctor as soon as possible and inform him/her that you have just performed a self-test for HIV and that the result was positive; - the self-test result must be confirmed by a test carried out in a laboratory; - protect yourself and protect others. warnings If you think you may have been exposed to HIV in the past 3 months, a negative test result is not guaranteed at this time. Therefore, avoid any activity that could lead to the transmission of HIV to other people. Use condoms to protect yourself and your partners. You will need to repeat the self-test three months after your most recent risk of HIV exposure. The self-test is intended for strictly private use as a self-test for HIV, and should not be used for other diagnostics or other purposes under any circumstances. - The self-test should only be used with a freshly drawn capillary blood sample, following the instructions in this document. Do not use with serum or plasma samples. - The self-test is a single-use device. Do not reuse. - Do not open the foil pouch containing the self-test until you are ready to perform the test. This self-test should not be used in the monitoring of patients on antiretroviral therapy. - Anyone using this self-test should consult their doctor before making any therapeutic decisions, regardless of whether the result is positive or negative. False positive (0.2% in studies on test specificity) or false negative results may be caused by the following circumstances: exposure to HIV in the three months prior to test use (window period), situations of advanced immunodeficiency or infection with a rare variant, or testing performed on HIV-positive subjects undergoing antiretroviral therapy. The test result may also be incorrect due to failure to store the product according to instructions or failure to comply with usage limits. - Do not use the self-test if the packaging or foil pouch has been opened or damaged. - Do not use the self-test if the expiration date written on the package has passed. - If you have difficulty understanding the explanations on the packaging or the instructions for use, contact Mylan immediately at the telephone number: +39 02 61246462. - Keep the self-test and all packaging contents out of the reach of children. The components of the HIV self-test can be dangerous if swallowed and can cause irritation. Autotest VIH provides an additional HIV testing option that can be used to complement other existing options. Autotest VIH can only diagnose HIV infection and cannot be used to test for other sexually transmitted diseases. AAZ-LMB expressly disclaims any responsibility relating to the use or distribution of the HIV self-test or any of its components, which occurs without strict compliance with the indications and limits of use specified in the instructions for use. Conservation Store the self-test in the original packaging, in a cool, dry place, at a temperature between 8°C and 30°C. Keep away from sunlight. Format - 1 aluminum sachet containing: 1 self-test, 1 cap containing the buffer solution, 1 safety scalpel, 1 patch; - 1 test tube holder; - 1 sterile gauze; - 1 disinfectant wipe; - 1 sheet of instructions