FDA authorizes first independently verified SARS-CoV-2 antibody test
The Food and Drug Administration yesterday authorized the first serology test in which independent federal data provided the scientific evidence used to support the authorization.
EUROIMMUN US Inc.’s Anti-SARS-CoV-2 ELISA (IgG) test, which will aid in identifying individuals with an adaptive immune response to SARS-CoV-2, is certified for emergency use by Clinical Laboratory Improvement Amendments-certified labs.
FDA said the results that secured the test’s authorization are among the first to come from a collaborative effort by the FDA, National Institutes of Health, Centers for Disease Control and Prevention and Biomedical Advanced Research and Development Authority to evaluate certain serological tests.
Related News Articles
Headline
Respiratory illness activity remains high across the country, according to the latest data from the Centers for Disease Control and Prevention. Seasonal flu…
Headline
The Occupational Safety and Health Administration Jan. 13 announced that it terminated efforts to establish a final COVID-19 safety standard to protect workers…
Headline
The Department of Health and Human Services Dec. 10 amended the Public Readiness and Emergency Preparedness Act declaration for COVID-19, extending liability…
Headline
AHA's latest social media toolkit for encouraging vaccination against the flu and COVID-19 provides fall-themed social media posts and graphics. Download the…
Headline
The Centers for Disease Control and Prevention last week endorsed a recommendation for people aged 65 and older and for immunocompromised individuals to…
Headline
The Centers for Medicare & Medicaid Services Oct. 22 released final guidance detailing reporting requirements for the hospital respiratory data condition…