FDA Grants EUA To iHealth's COVID-19 Self-Test Kit
iHealth Labs has received the FDA’s Emergency Use Authorization (EUA) for over-the-counter sale of its COVID-19 Antigen Rapid Test.
iHealth’s current production capacity is 100 million COVID-19 tests per month, but it will increase that to 200 million tests a month starting in January, according to Jack Feng, partner of the Sunnyvale, Calif.-based company.
The test uses a noninvasive swab, with results available on the iHealth COVID-19 Antigen Rapid Test app for iOS or Android phones. In a clinical trial, the iHealth test correctly identified 94.3 percent of positive specimens and 98.1 percent of negative specimens.