NEW YORK ─ The US Food and Drug Administration on Friday granted Emergency Use Authorization to Mountain View, California-based iHealth for its COVID-19 Antigen Rapid Test, a lateral flow assay, for use at home without a prescription to detect the SARS-CoV-2 nucleocapsid protein.
The FDA authorized the test for use with self-collected anterior nasal swab samples from individuals aged 15 years or older with symptoms of COVID-19 within the first seven days of symptom onset, and with anterior nasal swab samples collected by adults from individuals aged two years or older with symptoms of COVID-19 within the first seven days of symptom onset.
The agency also greenlighted the test for use with self-collected anterior nasal swab samples from individuals aged 15 years or older, or anterior nasal swab samples collected by adults from individuals aged two years or older. These individuals may or may not have SARS-CoV-2 symptoms, or there may be other epidemiological reasons to suspect COVID-19 when the individuals are tested twice over three days with at least 24 hours, and no more than 48 hours, between tests, the FDA said.