FDA has issued emergency use authorization (EUA) for virtually guided at-home use of Abbott’s BinaxNow Covid-19 Ag Card rapid test for detection of covid-19 infection. Results are delivered in minutes without the need to send out for processing.
The test is authorized for prescription use at home with self-collected nasal swab samples from individuals ages 15 years or older who are suspected of covid-19 by their healthcare provider within the first 7 days of symptom onset. It is also authorized for use with adult-collected nasal swab samples from individuals ages 4 years or older who are suspected of covid-19 by their healthcare provider within the first 7 days of symptom onset.
The test will be offered in partnership with eMed, a telehealth service that will take users step-by-step through the sample collection process and provide assistance in reading and understanding the results. The telehealth provider will also report all test results to the relevant public health authorities in accordance with local, state, and federal requirements.
“With today’s authorization of the BinaxNow Covid-19 Ag Card Home Test, there are now three tests that can be used completely at home,” says Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health. “We will continue to work with test developers to support the availability of more innovative testing options.”
Abbott and eMed expect to deliver and administer 30 million BinaxNow at-home tests in the first quarter of 2021, with an additional 90 million in the second quarter.
The eMed service offering costs $25 per test, and eMed takes care of determining eligibility, the guided self-collection process, and public health reporting requirements, and it gets people their results through an app in a matter of minutes.