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Beijing Hotgen Biotech Nabs FDA EUA for COVID-19 Antigen Test

NEW YORK – The US Food and Drug Administration said recently that it has granted Beijing Hotgen Biotech's COVID-19 antigen test Emergency Use Authorization.

The Hotgen COVID-19 Antigen Home Test qualitatively detects the nucleocapsid protein from SARS-CoV-2 via anterior nasal swab samples. The lateral flow assay is authorized for use by people with symptoms of COVID-19 within the first week of symptom onset when tested at least twice over three days with at least 48 hours between tests, the FDA noted in its authorization document. It is also authorized for use by people without symptoms when tested at least three times over five days with at least 48 hours between tests. The test returns results in about 15 minutes.