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HIV Self-Test for All: Approval approved by medical professionals


Despite certain risks, virologists advocate self-testing for HIV

The introduction of an HIV self-test could significantly reduce the number of unreported cases of HIV infection, experts from the Society for Virology (GfV) report. The association explains the advantages and disadvantages of the HIV self-test in a press release on the occasion of World AIDS Day.

Rapid tests for HIV antibody detection for self-testing have been approved in various countries for several years. "The background is the wish that all infected people know about their infection at an early stage," reports the GfV. The introduction of the HIV self-test could significantly reduce the proportion of patients who only learn about their HIV infection at the stage of AIDS and therefore have a poorer treatment success, and at the same time reduce the risk of infection from people with undetected and untreated infection. reduce, so the advice of the professional society.

High number of unreported cases of HIV infection

Around 88,400 people were living with HIV in Germany at the end of 2016 and an estimated 12,700 of those affected did not know that they were infected with the HI virus, according to the GfV, citing the figures from the Robert Koch Institute (RKI). The high number of unreported cases is problematic for two reasons. On the one hand, therapy should start as early as possible after the infection, and on the other hand, these people could inadvertently infect other people. The approval of an HIV self-test, similar to the pregnancy tests that can be carried out at home, would, according to the experts, bring about a reduction in the number of unreported cases.

Certain risks of self-testing

In a current statement, the GfV therefore spoke in principle for the approval of the HIV self-tests. However, the experts also point out certain risks associated with the tests. This should be "minimized as far as possible." Professor Dr. med. Josef Eberle from the Max von Pettenkofer Institute at the Ludwig Maximilians University in Munich emphasized in a press release from the "Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgemeinschaft eV" that, despite the many, including anonymous and free, offers for an HIV test, not all infected people can be reached become.

So far, distribution to private individuals is prohibited

“It is striking that, for years, the infection in unchanged over a quarter of new HIV diagnoses has only been diagnosed when the affected person is already ill or the number of T helper cells is below 350 / µl, which corresponds to an advanced HIV infection "Said Prof. Eberle. According to the expert, the self-test opens up good opportunities for improving the early diagnosis rate. However, such a test in Germany may not yet be given to private individuals. Currently, however, it is being examined whether the medical device levy regulation should be changed accordingly.

Good experience with the HIV self-tests

First experiences from England, where the test is already approved, are promising, according to the GfV. The test is easy to use and there is hardly any report of panic reactions as a result of false positive test results. Nevertheless, there are certain problems, according to the GfV. This applies, for example, to the quality of the self-tests. For example, "HIV rapid tests with CE mark that use fingertip blood can be compared to fourth-generation HIV laboratory tests", but they are inferior to laboratory tests for infection detection if they are at a very early stage infection is carried out, explains Prof. Eberle.

Test result is not always reliable

The limited reliability of the test results can result in people suffering from a false sense of security, "and at a time when the risk of transmission is particularly high," said the expert. This risk exists even more with self-tests that do not use blood, but a special oral swab (oral fluid) as test material. According to the virologist, it is also problematic that the user might misinterpret the test results. Because only three months after a possible infection did the self-test deliver a reliable result. Tests carried out beforehand are only of limited significance. In addition, according to the experts, the tests always show a certain error rate, so that a positive or negative result can be wrong. For this reason, the result of a test in a specialist laboratory is checked by means of a confirmation test before those affected are informed.

Delivery to private individuals required

In spite of the concerns, the GfV experts believe that submitting self-tests to private individuals should be supported "in order to prevent the further spread of HIV infection and to enable infected people to start treatment early." However, it must "be ensured that the tests are clear Contain information on how to deal with the results, ”says Professor Eberle. This includes the reference to "the three-month period and the possible error rate, as well as the recommendation to have it checked again in the event of a positive or unclear finding using a laboratory-based procedure and, if necessary, to also seek psychological help."

According to the GfV, users of the HIV self-test should also be informed that up to 72 hours after a possible infection there is the possibility of post-exposure prophylaxis (PEP) using HIV medication. In addition, the GfV advocates scientifically monitoring the effectiveness of the tests based on the parameters "new infections" and "proportion of patients with late diagnosis". (fp)

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