A new at-home COVID-19 test offers quick results at a lower cost than previously available tests. The FDA this week issued Emergency Use Authorization (EUA) for virtually guided at-home use of its BinaxNOW™ COVID-19 Ag Card rapid test.
Abbott said the new test provides results in minutes, without requiring consumers to send off a sample and wait days or weeks for results. At $25, the test is also much less expensive than previously available tests.
“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,” said Jeff Shuren, M.D., J.D., 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 has partnered with digital health solutions provider eMed™ to help manage distribution and administration. The companies said they expect to deliver 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 a test, and eMed takes care of determining eligibility, the guided self-collection process, public health reporting requirements and gets people their results through their NAVICA app in a matter of minutes.
“As the pandemic has evolved, the need for rapid testing has only grown. Unfortunately, we’re still hearing that many people can’t access testing as quickly as they need it,” said Robert B. Ford, Abbott’s president and chief executive officer. “That’s why Abbott is bringing our rapid BinaxNOW test and NAVICA platform into homes through this partnership with eMed, which allows us to maintain the integrity of the testing process, get even closer to people who need testing and help provide the confidence we need to help get back to living with a bit more normalcy.”
Abbott, which also produces other types of COVID tests, says it has ramped up capacity to 50 million tests a month in its U.S. facilities that are currently being distributed through the federal government and is expanding further so even more people have access to the tests.
“COVID-19 is the greatest public health threat our nation has experienced in a century,” said Dr. Patrice Harris, CEO of eMed. “This pandemic has had devastating effects in every region of our country but particularly on seniors, essential workers and communities of color. FDA’s authorization of Abbott’s BinaxNOW test for home use is a breakthrough in the battle against COVID-19.”
How it works
A person can access the eMed service through Abbott’s NAVICA app, which can be downloaded from the Apple and Android app stores. Once eligibility requirements are met, the test kit is shipped directly to the home user or a pick-up location, allowing a person to remain isolated until their status is known.
Once a BinaxNOW test kit arrives at the home, the home user logs into the eMed portal for their guided testing session and can expect results in approximately 20 minutes. The eMed certified guide is available to answer questions throughout the testing process.