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BioTeke Nabs FDA EUA for COVID-19 Rapid Antigen Test

NEW YORK – The US Food and Drug Administration this week granted Emergency Use Authorization for BioTeke USA's home-use rapid antigen test for COVID-19.

The Bio-Self COVID-19 Antigen Home Test, marketed by the Miami subsidiary of Wuxi, China-based BioTeke, is a lateral flow immunoassay designed for qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen from anterior nasal swab samples and delivers results in 15 minutes. The test kit is comprised of a test cassette, sample tube and cap, nasal swab, and waste bag.

The test is authorized for use with self-collected swab samples from adults and children ages 14 and older as well as with adult-collected swabs for children ages 2 years and older. The test is intended for use within seven days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and it can be used in people without symptoms when tested at least three times over five days with at least 48 hours between tests.