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iHealth Labs COVID, Flu Antigen Test Gets FDA EUA

NEW YORK – iHealth Labs announced Wednesday that its antigen test for COVID-19 and influenza A/B has received Emergency Use Authorization from the US Food and Drug Administration. 

The 3-in-1 COVID-19/Flu A&B Rapid Test Kit provides results in 15 minutes and is intended for at-home use, the company said in a statement. The lateral flow immunoassay qualitatively detects SARS-CoV-2, influenza A, or influenza B nucleocapsid protein antigens in anterior nasal swabs. 

The assay is authorized for over-the-counter use in people 2 years old and above, with assistance from an adult required for those between ages 2 and 13. The test is similar to iHealth's COVID-19 standalone test but requires five drops of a sample mixture onto a test card instead of three, the Sunnyvale, California-based firm noted. 

"The release of the 3-in-1 test demonstrates iHealth's ongoing dedication to provide convenient, accessible, and affordable testing to consumers and enable them to proactively manage their own health from the comfort of their home or wherever they are," iHealth CEO Jack Feng said in a statement. "As we did with the standalone at-home COVID test during the pandemic, our goal now, with this second generation of at-home testing that introduces combination tests such as the 3-in-1, is to evolve with consumer and public healthcare needs to deliver products that address immediate concerns."