www.fdanews.com/articles/196496-fda-clears-first-coronavirus-antibody-test-for-use-during-pandemic
FDA Clears First Coronavirus Antibody Test for Use During Pandemic
April 2, 2020
The FDA has awarded Cellex an Emergency Use Authorization for its qSARS-CoV-2 IgG/IgM rapid diagnostic test, the first coronavirus antibody test to receive the authorization.
The test detects IgG and IgM antibodies in the blood of patients suspected to have COVID-19 but is limited to use in authorized laboratories.
The FDA said that based on the evidence the company presented, “it is reasonable to believe that [the] product may be effective in diagnosing COVID-19” despite certain risks it didn’t elaborate on.