FDA Authorizes COVID-19 Test for Home Use With a Prescription

Abbott and eMed expect to deliver and administer 30 million BinaxNOW tests in the first quarter of 2021
i phone in a user's hand
(Coronavirus Today)

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization for the BinaxNOW COVID-19 Ag Card Home Test for patients at home with a prescription. 

This COVID-19 test is authorized for 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 seven days of symptom onset. 

The test is also authorized for use with adult-collected nasal swab samples from individuals ages four years or older who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.

The FDA stated in a press release on December 16, 2020, and the test is offered in partnership with a telehealth service that will take users step-by-step through the sample collection process and help read and understand the results. The telehealth provider will also report all test results to the relevant public health authorities following local, state, and federal requirements. 

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

In general, antigen tests are precise for COVID-19 but are not as sensitive as molecular PCR tests. This means the test has a greater chance of producing false negatives than with many molecular tests. 

Positive results from antigen tests, while generally highly accurate, may be subject to false-positive results, especially in areas where there are fewer infections.

Individuals with positive results should self-isolate and seek additional care from their health care provider. Negative results do not preclude an individual from SARS-CoV-2 infection. Individuals who test negative may need additional testing, particularly those who continue to experience COVID-like symptoms.

The service uses Abbott's complementary NAVICA™ app to enable the testing process and display authenticated BinaxNOW test results verified by a trained guide and supports consumer confidence in testing at home.

A person can access the eMed service through Abbott's NAVICA app, 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 them 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.

The eMed service offering costs $25 a test, and eMed takes care of determining eligibility, the guided self-collection process, public health reporting requirements.

Abbott Diagnostics Scarborough, Inc.’s BinaxNOW COVID-19 Ag Card, a different product than this home-use test, was authorized by the FDA for use at the point-of-care in August 2020.

As of December 14, 2020, the U.S. FDA authorized 299 coronavirus diagnostic tests, including 230 molecular tests, 61 antibody tests, and eight antigen tests this year.

Furthermore, the U.S. CDC updated data indicates over 217 million RT-PCR diagnostic tests, excluding antibody and antigen tests, have been performed to confirm if a person has a SARS-CoV-2 virus infection.

The FDA is an agency within the U.S. Department of Health and Human Services that protect public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, other biological products for human use, and medical devices.

CoronavirusToday publishes research-based news.