AUTOTEST VIH HIV-S

AUTOTEST VIH HIV-Selbsttest ratiopharm

Product features

ratiopharm autotest VIH

Instructions for use:

• autotest VIH is an HIV test (HIV is the virus responsible for AIDS) based on a blood sample from the fingertip.
• This self-test allows reliable detection of an HIV infection if the infection occurred at least 3 months ago.
• autotest VIH is a diagnostic in vitro test for single use.
• autotest VIH is intended for use by a layperson in a private setting.
• It takes about 5 minutes to perform the test and 15 minutes to read the result.
• You will need a watch or timer.
• Please read the instructions carefully before using the test.

Function and performance of the test

autotest VIH is an immunochromatographic test that detects antibodies in human blood that are produced after an HIV infection. The control line, which appears when the test is used, serves to confirm that the test is functioning properly.

Warnings and precautions:

• The HIV self-test is intended for personal use only and must not be used for any other diagnosis or purpose under any circumstances.
• The HIV self-test may only be used with a fresh sample of capillary blood.
• Do not use for serum or plasma samples.
• Store the HIV self-test in its original packaging in a cool and dry place between 8°C and 30°C. Protect from sunlight.
• The HIV self-test is intended for single use only. It should be performed between 18°C and 30°C. Do not reuse.
• Do not open the foil pouch containing the self-test until you are ready to perform the test.
• This self-test is not intended for use by patients receiving antiretroviral therapy.
• Users of this self-test should talk to their doctor before making any medical decisions - regardless of whether the test result is negative or positive.
• False positive results (0.2% in test specificity studies) or false negative results may occur under the following circumstances:
  • Risk contact with HIV-infected persons within 3 months of using the test (diagnostic gap),
  • advanced immunodeficiency or infection with a rare HIV variant,
  • use in HIV-positive individuals receiving antiretroviral treatment.
  • Incorrect storage or exceeding the expiration date can also cause false test results.
• Do not use the self-test if the packaging or foil pouch is open or damaged.
• Do not use the self-test if the expiration date on the package has been exceeded.
• If you do not understand the instructions for use correctly, you should contact one of the contacts listed above.
• Keep this self-test and its components out of reach of children, as the components of autotest VIH can be harmful if swallowed and can cause irritation.
• autotest VIH is an additional form of HIV testing that can be used in addition to other options, autotest VIH can only detect HIV infections and cannot be used as a test for other sexually transmitted infections.

AAZ-LMB expressly disclaims any liability for the use or distribution of autotest VIH or its components if the instructions and limitations of use specified in the instructions for use are not observed.

Source: Information from the package insert
Status: 12/2019