The National Agency for the Safety of Medicines and Health Products (ANSM) indicated on Wednesday February 17 the prohibition on the sale and use in France of a self-test for Covid-19 on urine, non-compliant and without "
any proof
" of effectiveness.
Read also: Covid-19: Did France take too long to authorize saliva tests?
The ANSM indicates this Wednesday to have been "
informed of the advertisement
" on this self-test called "
Sars-CoV-2 Urine Antibody Rapid test
" which would make it possible to detect the presence of antibodies in the urine.
"
We have no proof of the effectiveness of this test, given that antibodies, in general, are not found in the urine,
" asserts the health agency.
In addition, the manufacturer has not obtained the certificate of conformity from a notified body for the marketing of this test.
"
This test is manufactured by the companies Inno-Bio (Shanghai) and Olisacare and distributed in France by the companies Biomadetech and MedicSante
".
The sale of self-tests (except pregnancy tests) is also reserved for pharmacies.
It further recalls that in the context of the state of health emergency (decree of July 10, 2020), the use of self-tests is prohibited to detect the Covid-19 virus, SARS-CoV-2, as well as the antibodies directed against this virus.
This decision to suspend the sale and even free transfer of this self-test was signed on January 29 by the Director General of the ANSM, Dr Christelle Ratignier-Carbonneil.
The ANSM asks people who have purchased these tests not to use them and reminds that only tests with a CE marking and validated by health authorities can be used, whether it is a serological test ( available in pharmacies or performed in a medical biology laboratory), an antigen test (available in pharmacies) or an RT-PCR test (in a medical biology laboratory).
All the tests that can be used in France are listed on the ministry's website (https://covid-19.sante.gouv.fr/tests).