The French company AAZ obtained the CE marking, necessary for the marketing of the first HIV self-test. It will be sold in pharmacies and on the internet from the end of June.
The Department of Health has authorized the use of self-testing for HIV blood. The French company AAZ has obtained the CE standard for its ” HIV self-test “. This marking, which is a label ensuring the product’s conformity with European standards, is necessary for the marketing of the product in France. They will be available without a prescription from the end of June in pharmacies and on their websites, between 25 and 28 euros.
This self-test makes it possible, from a drop of blood taken from the fingertip, to identify in fifteen minutes the presence or absence of specific antibodies produced in the event of infection by the AIDS virus.
Since Monday, individual tests called ” BioSURE HIV Self Test Are on sale in the UK, on the internet for around 42 euros (£ 29.95).
HAS recommendations
Last February, the Haute Autorité de Santé disseminated an information note, in the form of questions and answers, intended for healthcare professionals and associations in contact with users of the self-test. She recalls that it is “a complementary tool to the current system and it should not replace it”.
Indeed, even if these self-tests make it possible to improve screening, they are nevertheless not 100% reliable. “Any positive result must be confirmed by a laboratory test,” we can read. A negative test does not necessarily mean that the person tested and their partner (s) are not infected with HIV ”.
In addition, they are not very sensitive in the event of recent infection, less than 3 months, and above all, this self-test does not detect other sexually transmitted diseases.
Target exposed populations
Despite these limitations, self-tests are enthusiastically received by associations fighting against HIV, which have been experimenting with TRODs for several years (Rapid Diagnostic Orientation Test). “They make it possible to reach the populations most exposed to the risks, who do not go towards a traditional screening offer, explained on April 17, Théau Brigand, of the association Aides à Why actor. It is much easier to have access to these people if you have a varied offer ”.
Less stressful, less invasive and easier to perform than those of screening centers, these tests allow these associations to set up support throughout the care process, from screening to treatment of the disease.
In France, 20% of people infected with HIV are unaware of their HIV status. These self-tests would undoubtedly make it possible to go further in the fight against the disease, but above all to improve access to screening for all.
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