The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for iHealth Labs鈥� new COVID-19/Flu A&B rapid test kit.
Intended to deliver results in 15 minutes, the 3-in-1 test kit is said to be one of the first over-the-counter rapid antigen tests for both Covid-19 and influenzas A and B in the US.
It is used for self-testing at home and is suitable for individuals aged two and above, with adult assistance required for children between the ages of two and 13 years.
Building on the user-friendly design of iHealth’s standalone at-home Covid test, the new test requires five drops on the test card, a slight increase from the previous three drops.
The lateral flow immunoassay displays results for Covid-19, influenza A, and influenza B.
The iHealth COVID-19/Flu A&B Rapid Test is designed for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens.
US Tariffs are shifting - will you react or anticipate?
Don鈥檛 let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataiHealth CEO Jack Feng said: 鈥淚n the face of uncertainty surrounding symptoms such as fever, sneezing, cough, or fatigue and what illness they may be indicative of, our at-home 3-in-1 self-test offers peace of mind for parents who might be worried that their vulnerable young children have Covid-19 or the flu.
鈥淎s we did with the stand-alone 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.鈥�
Only those who have respiratory infection symptoms and indications consistent with Covid-19 within the first four days of symptom onset, are eligible for this test.
Last year, iHealth Labs said it manufactured more than 70 million Covid-19 at-home test kits at its facility in Irwindale, California.
