iHealth Labs’ COVID-19 Test Granted FDA’s Emergency Use Authorization

The FDA’s has granted Emergency Use Authorization to Sunnyvale, Calif.-based iHealth Labs’ COVID-19 Antigen Rapid Test Pro, which detects SARS-CoV-2 antigens from nasal swab samples.

The test is authorized for individuals who are suspected by their healthcare providers of having COVID-19, within the first seven days of symptom onset. It may also be used for asymptomatic 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 assay does not differentiate between the SARS-CoV-2 virus, which causes COVID-19, and SARS-CoV, which caused a more limited outbreak of respiratory illness in 2003.