Summary: iHealth Labs received FDA Emergency Use Authorization for its COVID-19/Flu A&B Rapid Test Kit, enabling self-testing at home with results available in 15 minutes.
Takeaways:
- The 3-in-1 test kit delivers quick at-home results for COVID-19, Influenza A, and Influenza B in 15 minutes.
- The test, suitable for individuals aged 2 and above, features simple steps for accurate results and requires only five drops per test card.
- The FDA-backed test aligns with efforts to increase access to home testing, helping families manage health with rapid identification and appropriate care.
iHealth Labs announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the company’s 3-in-1 COVID-19/Flu A&B Rapid Test Kit for self-testing at home.
Quick OTC COVID and Flu Testing
The over-the-counter rapid antigen test for COVID-19 and influenza (commonly known as the flu) A & B in the US, provides results in 15 minutes for convenient and fast at-home testing.
The 3-in-1 test is suitable for individuals aged 2 and above. Assistance from an adult is required for children aged 2-13. The 3-in-1 test inherits the same user-friendly steps of iHealth’s stand-alone at-home COVID test. The difference lies in squeezing five drops onto a test card, compared to the previous 3 drops. Results for COVID-19, Influenza A or Influenza B are displayed in 15 minutes.
Post-Pandemic Home Tests
With the launch of the 3-in-1 COVID-19/Flu A&B Rapid Test, iHealth, one of the leading suppliers of at-home COVID tests to the federal government, ushers in a new era of at-home testing post-pandemic that will enable consumers to stop guessing what illness they may have when symptoms emerge.
During the height of the pandemic, iHealth delivered over 1 billion at-home COVID tests in the now well-recognized orange box packaging, throughout the country. The company recently won a tech innovation company of the year award from the city of Sunnyvale where it is headquartered, for its immense capacity to rapidly scale up to produce and distribute COVID tests to as many people as soon as possible.
Physicians also emphasize the heightened vulnerability of children to common viruses, especially during the school season, making this continually a focus of concern for parents, iHealth says. According to the National Library of Medicine, children are particularly susceptible to influenza infections and serve as the primary contributors to the transmission of the virus.
“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,” says Jack Feng, CEO of iHealth. “They don’t need to prolong the worrying and waiting for answers—experience the assurance of instant results within 15 minutes. This allows for appropriate medical care tailored to the particular virus, easing concerns for you and your family.”
The FDA, in recent statements, has expressed its advocacy and support for test innovation and working with test developers to advance availability and greater access to at-home infectious disease testing to best support public health needs. The 3-in-1 self-test from iHealth aligns seamlessly with this vision, empowering individuals to take prompt actions based on quick results, ultimately contributing to their safety and well-being.
“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,” says Feng. “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.”
