Mon, 06 Dec 2021

Non-prescription COVID test approved by U.S. FDA

Robert Besser
06 Apr 2021, 20:47 GMT+10

WASHINGTON D.C.: The U.S. Food and Drug Administration has given approval to two additional at-home COVID-19 screening tests, to be purchased over-the-counter.

In an announcement late last week, the FDA said the approvals were given to "get more tests for screening asymptomatic individuals on the market."

Approved were BinaxNOW COVID-19 Antigen Self Test by Abbott Laboratories, a U.S. medical device company, and the QuickVue At-Home OTC COVID-19 test by Quidel Corporation, a U.S. diagnostics healthcare products manufacturer.

"Screening testing, especially with the over-the-counter tests authorized today, is an important part of the country's pandemic response -- many schools, workplaces, communities and other entities are setting up testing programs to quickly screen for COVID-19," said Jeff Shuren, director of the FDA's Center for Devices and Radiological Health. "As the pandemic has progressed, we have worked with test developers wishing to add screening claims," as quoted by Reuters.

The FDA had earlier approved both products, but only to be used for patients showing symptoms of the Coronavirus. With this new approval, the test can be used for all people wishing to be tested for COVID-19.

In a statement, Abbott noted that its nasal swab test can be used on children as young as two years old.

Abbott officials added that it can produce 50 million tests per month. The U.S. Department of Health and Human Services has ordered Abbott's first 150 million tests to send to K-12 schools, nursing homes, historically Black colleges and universities, and underserved communities.

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