The Belgian competent authority (FAGG/AFMPS) has banned the supply and use of rapid diagnostic self-tests for the coronavirus (COVID-19) for six months. The purpose of the ban is to avoid misinterpretations of negative results generated from use of the tests.
Belgium has adopted the Royal Decree of 17 March 2020 concerning the prohibition of supply, putting into service and use of rapid tests for the measurement or detection of antibodies of SARS-COV-2 VIRUS.
The Royal Decree prohibits the sale of a group of in vitro diagnostic medical devices for the rapid self-measurement or self-detection of COVID-19-related antibodies, such as IgG, IgM, and IgA for a period of six months.
The background of the ban is provided on the FAGG/AFMPS website. It is explained that rapid self-tests to detect the coronavirus (COVID-19) are able to give a positive result only when a few days have passed after infection with the virus. If the test is conducted shortly after the patient has had a questionable contact or just after the appearance of the virus symptoms the self-test may give a false negative result. As a consequence, the patient is able to continue to pass the COVID-19 virus to other people in the belief that they are not ill.
The Royal Decree provides, moreover, that an inexperienced user could misinterpret the result in a self-diagnosis using IgM detection tests due to a lack of scientific knowledge. There is also a risk that these tests will give false positive results that may lead to physicians advising treatment or measures concerning healthy patients.
The Royal Decree also provides that the use of tests based on antibody detection may also lead to a misinterpretation of the condition of the patient. This is because the suitability of this test for the detection of COVID-19 has not yet been demonstrated. The patient may be a carrier of the COVID-19 virus despite a negative test result.
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