Even if there are online shops offering serological tests for home use, currently, such products cannot be on the market legally. Therefore, buying tests for home environment is strongly not recommended, and selling them is strictly prohibited.
According to the current European regulation, the documentation of in vitro diagnostic (IVD) devices designed for home use must be examined by a notified body before the device can be sold in the EU. This notified body issues the necessary certificates (CE mark), and the process lasts for at least 6 months. Therefore, it is not possible that any manufacturer has already obtained a CE mark for a non-professional use diagnostic test.
Moreover, in Hungary, IVD devices count as medical devices and can be sold only in licensed medical device stores and/or pharmacies. Selling them in any other shops – including online shops – is prohibited.
COVID-19 diagnostic tests designed for professionals are not recommended for non-professional use either.
False positive or negative results may lead to an unnecessary anxiousness or false sense of security. Moreover, performing a test without professional supervision makes the search and isolation of infected people impossible, which seriously impedes the efficient prevention and/or slowing down the pandemic.