US-based medical device firm iHealth Labs has received the US Food and Drug Administration (FDA) emergency use authorisation (EUA) for its 3-in-1 Covid-19/Flu A&B Rapid Test Kit.
The Covid-19/Flu A&B Rapid Test is a lateral flow immunoassay designed to detect and differentiate between SARS-CoV-2, influenza A, and influenza B protein antigens.
It is one of the first over-the-counter rapid antigen tests for Covid-19 and influenza A and B in the US, intended for self-testing at home and offers results within 15 minutes.
The three-in-one rapid test kit can be used by individuals aged two years and above, and children aged below 13 are required to take assistance from an adult.
The test is authorised only for people with signs and symptoms of Covid-19, used within the first four days of symptom onset when tested at least twice over three days.
iHealth CEO Jack Feng said: “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.
“This allows for appropriate medical care tailored to the particular virus, easing concerns for you and your family.
“Parents with multiple kids, with testing of a child who has symptoms of illness, can also protect their other kids from catching the illness with early detection.
“And imagine the time that is saved if several of your kids or other family members might have the flu or Covid and the hassle you are alleviating by testing them all at home instead of the entire family having to head to the doctor’s office.”
Recently, the US FDA has supported work with test developers to advance the availability and enhance access to at-home infectious disease testing to better address public health needs.
iHealth said that its new three-in-one self-test complements the FDA’s vision and helps individuals take actions based on quick results, contributing to their safety and well-being.
Feng added: “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.
“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.”
