FDA issues EUA for at-home use of Abbott’s Covid-19 rapid test

17 December 2020 (Last Updated December 17th, 2020 11:27)

The US Food and Drug Administration (FDA) has issued Emergency Use Authorisation (EUA) for Abbott’s virtually guided at-home use of its BinaxNOW COVID-19 Ag Card rapid test for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.

FDA issues EUA for at-home use of Abbott’s Covid-19 rapid test
A home user places drops of the reagent into the Abbott BinaxNOW COVID-19 Home Test, while the eMed certified guide supports the process. Credit: Abbott.

The US Food and Drug Administration (FDA) has issued Emergency Use Authorisation (EUA) for Abbott’s virtually guided at-home use of its BinaxNOW COVID-19 Ag Card rapid test for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.

Authorised for prescription home use, the test can be conducted using self-collected observed direct anterior nasal (nares) swab samples from people aged 15 years or above with suspected Covid-19 by a healthcare provider in seven days of onset of symptoms.

For individuals aged four years or older, the sample can be collected by adults.

The portable, easy-to-use, 15-minute antigen test needs no instrument and detects the virus when people are most infectious.

Abbott claimed that with $25 cost for the test and service, BinaxNOW is the most affordable at-home test that does not need to be sent out for processing.

Abbott collaborated with digital health solutions provider eMed to aid in the delivery of BinaxNOW test to home and for guided collection and testing process.

Along with BinaxNOW COVID-19 Ag Card Home Test, Abbott is offering an app called NAVICA, which displays results of the test.

To perform the test, the home user can log into the eMed portal for guided testing session and results will be delivered in about 20 minutes.

Abbott president and CEO Robert Ford said: “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.

“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 and eMed intend to deliver and administer 30 million BinaxNOW at-home tests in the first quarter of next year with an additional 90 million in the second quarter.

Earlier this week, Abbott received CE Mark for its new quantitative SARS-CoV-2 Immunoglobulin G (IgG) lab-based serology test that can measure a person’s immune response.