Paul-Ehrlich-Institut

HIV Self-tests

Helping with product selection - access to technical information

In Germany from autumn 2018 onward, you can buy HIV self-tests in pharmacies, drugstores or over the Internet. With an HIV self-test you can test at home, whether you have an HIV infection.

The tests are voluntary and easy to perform. The results are available within 15 minutes. In order to help you choose a suitable self-test we offer you product information at a glance, what these tests can do for you, which ones are approved and what else should be considered.

HI-Viren (Quelle: K. Boller / PEI)

Product list - Which HIV self-tests are ok?

Only tests with CE marks should be used because these tests fulfill the fundamental requirements for safety and performance as defined in Europe. Tests with CE marks are:

  • Simplitude ByMe HIV Self Test
    Distribution: Owen Mumford
    Instructions: Link
    User Video: Video
  • Autotest VIH
    Manufacturer: AAZ-LMB distribution: ratiopharm
    Instructions: Link
    User Video: Video
  • Biosure HIV Self Test
    Manufacturer: Biosure
    Instructions: Link
    User Video: Video
  • Exacto Pro HIV
    Manufacturer: Biosynex
    Instructions: Link
    User Video: Video
  • INSTI HIV Self-Test
    Manufacturer: bioLytical
    Instructions: Link
    User Video: Video

The CE mark of the listed HIV self-tests comes from the Eudamed database or from pieces of information provided to the Paul-Ehrlich-Institut (PEI).

The Internet offers also self-tests without CE marks, some of them are of questionable quality.

How does an HIV self-test work?

In case of an HIV infection, your immune system develops antibodies against the HI virus. A self-test provides evidence of these specific antibodies.

Please note: Only about 12 weeks after a suspected infection, the antibody concentration is high enough to get a meaningful HIV self-test result (diagnostic window).

The above-mentioned HIV self-tests detect the antibodies from a drop of blood. The concentration of antibodies in saliva or urine is lower than in blood, so tests based on blood are the most reliable.

When can I do an HIV self-test?

In case you decide to do an HIV self-test, a period of 12 weeks after a possible infection risk should have passed. Only then antibodies are present in such a high concentration that the test is meaningful.

In addition to HIV self-tests, there are HIV tests that detect an HIV infection at an earlier point in time (6 weeks after the infection risk). These tests are carried out at the doctor, health authorities or AIDS Aid. More information on these HIV tests can be found here.

Why are HIV self-tests after medication to prevent HIV infection not reliable?

There are medicines that can be taken to prevent HIV infection (HIV prophylaxis). You can differentiate between:

  • pre-exposure prophylaxis (PrEP), e.g. Truvada, taken before the risk of HIV infection, and
  • post-exposure prophylaxis (PEP), taken after an HIV infection risk.

These drugs do not guarantee a 100 per cent protection against HIV infection. In case of such an HIV break-through infection the multiplication of the virus may be inhibited but not prevented. This again may result in delayed or limited detection of the infection, and potential negative test results with an HIV self-test, despite the infection. It is possible that this medication causes a negative result in the HIV self-test despite an existing HIV infection.

Therefore this medication may be associated with a false-negative result in HIV self-tests, despite the HIV infection.

If you take a PrEP or PEP, please consult a doctor, a counseling center or a local AIDS Aid for further advice and testing.

What next with a positive result in the HIV self-test?

A positive test result does not always mean an HIV infection because cross-reactions can falsify the result. If the result is positive, always let a doctor or, anonymously, a public health authority (Gesundheitsamt) or the German AIDS Aid (Deutsche AIDS-Hilfe) do a confirmation test. Only confirmed results can be considered safe. Further information can also be found here.

An HIV infection can be treated very well. In confirmed HIV infection, doctors can prescribe medication that prevent the multiplication of the virus in the body. In Germany, people with HIV have a similar life expectancy like healthy people.

What about a negative result in the HIV self-test?

If there is a negative test result, there is no evidence of HIV infection. However, the result is only meaningful if the time span between possible infection time and test is greater than 12 weeks. Otherwise the test may result negative even though there is an HIV infection. Counseling centers are prepared to inform you if you have questions about the HIV test and how you can protect yourself from an HIV infection.

Where can I get more information and advice?

Physicians, HIV specialists, health authorities and other counseling centers are prepared to answer your questions.

  • BZgA: The Federal Center for Health Education (Bundeszentrale für gemeinschaftliche Aufklärung) informs with you with LIEBESLEBEN covering the topics HIV and STI (Sexually Transmitted Diseases), Safe Sex and Protection.
    There you will also find information on the HIV-Test. You can ask personal questions directly and, if you wish, get advice by phone and online from the BZgA anonymously: phone +49 (0) 221- 89 20 31 (price according to the price list of the telephone provider for calls to the Cologne local area network),
    online at www.liebesleben.de/beratung
  • German AIDS Aid (Deutsche AIDS-Hilfe): comprehensive information on HIV and HIV self-tests can be found here. You can get advice from German AIDS Aid via email or chat or telephone number 0180 33 19411 (Monday to Friday 9 a.m. to 9 p.m., Saturday and Sunday noon to 2 p.m., maximum 9 cents/minute from the German landline, 42 cents/minute from the German mobile networks).

What happens when problems with the HIV self-test occur?

In case of technical problems (e.g. in the process of the testing or when reading the results), please inform the manufacturer.

The manufacturer must evaluate reports from the users and pass on in case of problems (so-called incidents) when applying the test device.

You can also contact directly the Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedicines, using our registration form in case you cannot read a test result or you can demonstrate your doubts about the accuracy of the test result.

The PEI is the federal institute responsible for HIV test safety in Germany and, if necessary, can also, if necessary, order measures. Here you will find detailed information on the subject and more customer information of the manufacturer.

Updated: 15.05.2020