Skip to main content
Premium Trial:

Request an Annual Quote

IHealth Point-of-Care SARS-CoV-2 Antigen Test Receives FDA EUA

NEW YORK – The US Food and Drug Administration said last week that the iHealth COVID-19 Antigen Rapid Test Pro has received Emergency Use Authorization. 

The test qualitatively detects SARS-CoV-2 nucleocapsid antigens from anterior nasal swab samples. It is authorized for individuals with symptoms who are suspected of having COVID-19 by their healthcare provider within the first seven days of symptom onset. It can also be used for individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours and no more than 48 hours between tests, the FDA said.

The lateral flow immunoassay is intended for use at the point of care or in CLIA-certified laboratories.

Mountain View, California-based iHealth previously received EUA from the FDA in November for its COVID-19 Antigen Rapid Test for use at home without a prescription.