iHealth's COVID-19/Flu rapid test secures FDA EUA

Medical Devices DECODED

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iHealth's COVID-19/Flu rapid test secures FDA EUA

Intended for over-the-counter use, the 3-in-1 test is intended for detecting Covid-19 and influenzas A and B.

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for iHealth Labs’ 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.

iHealth CEO Jack Feng said: “In 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.

“As 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.”

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.

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