FDA Issues EUA for Abbott’s At-Home COVID-19 Antigen Test

December 21, 2020 - FDA recently issued an emergency use authorization (EUA) for Abbott’s COVID-19 antigen test, the BinaxNOW COVID-19 Ag Card Home Test, for use by patients with a prescription. 

The test is authorized for individuals 15 years of age or older who are suspected of COVID-19 by their healthcare provider and who are within the first seven days of symptom onset. The test can also be  use with adult-collected nasal swab samples from individuals four years of age and older who are suspected of infection, FDA stated.

“FDA continues to authorize COVID-19 tests that will give more Americans access to greater testing flexibility and options,” FDA Commissioner Stephen M. Hahn, MD, said in the announcement. “The BinaxNOW COVID-19 Ag Home Test will have a significant manufacturing footprint with the potential to support testing for millions of people.” 

The BinaxNOW COVID-19 Ag Card Home Test will be offered in partnership with a telehealth service that will help users successfully collect nasal swabs step-by-step and analyze the results.

Additionally, the provider will report all test results to necessary public health authorities following local, state, and federal requirements. 

Although antigen tests are specifically for COVID-19, they are not as sensitive as molecular PCR tests. This means that there is a higher chance of false negatives than with many molecular tests, FDA stated. 

Those individuals who receive positive results should self-isolate and seek additional care from their personal healthcare provider, the agency advised. But negative results do not prevent an individual from SARS-CoV-2 infection.

Anyone who tests negative on the BinaxNOW COVID-19 Ag Card Home Test may need to seek additional testing, particularly those who continue to experience coronavirus symptoms. 

“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, 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,” Shuren continued. 

Abbott’s BinaxNOW COVID-19 Ag Card, which is a different product than this authorized home use test, is authorized for use at the point-of-care under an EUA that was issued back in September.

Abbot’s BinaxNOW Ag Card is fast and efficient for healthcare providers and patients, taking just 15 minutes to provide results. The test does not need the use of an analyzer and is authorized for use at point-of-care settings, including doctor’s offices, emergency rooms, and some schools.

In previous data submitted to FDA, BinaxNOW COVID-19 Ag Card showed sensitivity of 97.1 percent (positive percent agreement) and specificity of 98.5 percent (negative percent agreement) in patients suspected of COVID-19 by their healthcare provider within the first seven days of symptoms

So far, Abbott has invested hundreds of millions of dollars since April in two new US facilities to manufacture BinaxNOW at a larger scale. 

And currently, the company is producing tens of millions of tests per month, as well as a mobile app for iPhone and Android devices so that individuals can display their test results when entering facilities that require proof of testing.

Following FDA’s authorization, HHS Secretary Alex Azar issued the following statement:

“FDA’s authorization of the BinaxNOW card test for home use means we should have tens of millions of COVID-19 tests in the coming months that Americans can use without leaving their home,” Azar said.

“HHS’s testing leadership have worked closely with companies like Abbott for months to accelerate the availability of these exciting new options, part of our commitment to bringing the best of the public and private sectors together to beat COVID-19,” he concluded.