FDA tightens scrutiny of coronavirus antibody tests

The US Food and Drug Administration (FDA) on Monday tightened its oversight of coronavirus antibody tests after the market was…

The US Food and Drug Administration (FDA) on Monday tightened its oversight of coronavirus antibody tests after the market was flooded with dubious tests.

Companies selling antibody tests, which determine whether someone has been infected with COVID-19, must submit data to prove their accuracy, the FDA said.

The agency had previously allowed companies to validate their own data from antibody tests, also known as serology tests.