Italy's DiaSorin gets U.S. FDA approval for COVID-19 antibody test

MILAN (Reuters) - Italian diagnostics group DiaSorin said on Saturday it had received an Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration for a serological test kit for COVID-19.

DiaSorin also said it had recently signed a contract with the Biomedical Advanced Research and Development Authority to obtain funding to make the test available in the United States.

DiaSorin’s kit for serological tests on intravenous blood samples is being used in Italy’s Lombardy region, the area worst hit by the coronavirus outbreak in the country.

Unlike nasal swab tests, which look for the presence of the coronavirus directly, serological tests look for antibodies that indicate viral contagion. Antibody tests are quicker and simpler to administer though doctors in Italy say they would have to be complemented with swab tests for complete security.

DiaSorin said its test would be available on the 5,000 LIAISON XL platforms installed worldwide, of which 600 are in U.S. hospitals and commercial laboratories. Such platforms can cope with 170 patient samples per hour, DiaSorin said.

Reporting by Valentina Za; Editing by David Clarke