FDA Authorizes Two Siemens COVID-19 Tests

Two COVID-19 tests made by Siemens Healthcare Diagnostics have received Emergency Use Authorization (EUA) from the FDA.

The Tarrytown, N.Y.-based subsidiary of the German tech giant has garnered the EUAs for its ADVIA Centaur SARS-CoV-2 Antigen (CoV2Ag) and Atellica IM (immunoassay) SARS-CoV-2 Antigen (CoV2Ag) tests.

The two immunoassays detect SARS CoV-2 nucleocapsid antigen from anterior nasal swab specimens from individuals who are suspected of COVID-19 infection by their healthcare providers within the first seven days of symptom onset.

Analysis of the tests is limited to laboratories that are certified to perform moderate- or high-complexity tests.