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Asymptomatic, Non-Prescription, OTC Self Use Test for People With or Without COVID-19 Symptoms Approved

April 1, 2021 • 1:51 pm CDT
(Coronavirus Today)

Abbott Park-based Abbott announced it had received U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for over-the-counter, non-prescription, asymptomatic use its BinaxNOW™ COVID-19 Ag Self Test for detection of COVID-19 infection.

This new indication allows individuals with or without SARS-CoV-2 coronavirus symptoms to have access to this test without a prescription.

Furthermore, Abbott stated in a press release issued on March 31, 2021, it will begin shipping the test to major food, drug, and mass merchandiser retailers in the coming weeks.

And, the test may become available through some online stores.

The test can be used on children as young as two years old when an adult collects samples and for all people aged 15 years or older, bringing the country's most extensively studied and widely used rapid antigen test to nearly everyone in the U.S. The test will come in a two-count box to meet frequent testing requirements.

"We've now accomplished what we set out to do when we launched BinaxNOW, which is to bring an accurate, affordable, and readily available test to the American people that they can have on hand, whether they want to test frequently or in certain circumstances," commented Robert B. Ford, president, and CEO, Abbott.

Abbott initially launched the BinaxNOW professional test nationwide in August 2020 and scaled-up production at its new U.S. manufacturing facilities to produce 50 million tests per month.

The U.S. Department of Health and Human Services purchased the company's first 150 million tests, sending them to K-12 schools, nursing homes, historically black colleges and universities, and underserved communities, where they remain in use today and serve as a powerful tool to help prevent the virus from spreading.

The BinaxNOW Self Test is the same technology as the existing BinaxNOW test.

Using the test will be simple, even for people who have never tested themselves. People will only need to perform a minimally invasive nasal swab (not the deep nasopharyngeal swab). All materials required to perform the test (swab, test card, and reagent solution) will come in the box, says Abbott.

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Abbott's portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional, and branded generic medicines. About 109,000 colleagues serve people in more than 160 countries.

Recent data compiled by Statista on March 22, 2021, indicates the USA leads all counties with 371 million COVID-19 tests processed, followed by India (234m) and China (160m).

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