FDA greenlights 1st COVID-19 neutralizing antibody test

2019 02 13 19 24 5396 Fda Logo V2 400

The U.S. Food and Drug Administration (FDA) has authorized the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection. Emergency use authorization (EUA) has been granted to GenScript USA's cPass SARS-CoV-2 neutralization antibody detection kit.

The authorization provides clinicians with a tool to evaluate antibodies as the SARS-CoV-2 virus continues to be researched. However, the FDA said patients shouldn't use the test results as an indication to stop taking steps to protect themselves and others from spreading COVID-19.

The agency also said serology tests should not be used to diagnose an active infection.

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