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FDA Grants Emergency Authorization to At-Home COVID Tests

The Food and Drug Administration (FDA) granted emergency use authorization Monday to Quidel QuickVue's at-home testing kit, providing another at-home option for those seeking a rapid coronavirus test result.

by Joseph Ostapiuk, Staten Island Advance / March 3, 2021
CARES Act funding has helped states cope with unanticipated COVID-related costs, such as testing taking place in Colorado. (Michael Ciaglo/Getty Images/TNS) TNS

(TNS) — The Food and Drug Administration (FDA) granted emergency use authorization Monday to Quidel QuickVue's at-home testing kit, providing another at-home option for those seeking a rapid coronavirus (COVID-19) test result.

"The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic," said Dr.  Jeff Shuren , director of the FDA's Center for Devices and Radiological Health. "The QuickVue At-Home COVID-19 Test is another example of the FDA working with test developers to bring important diagnostics to the public."

The test can be prescribed by a health care provider within the first six days of symptom onset, the company said. The test is authorized for individuals 14 and older to be able to self-swab, and samples can also be collected by an adult for children 8 years old and older.

The QuickVue test uses "lateral flow technology" that exposes a sample to a test strip to determine infection. Results, according to the company, can be obtained in 10 minutes.

Quidel said its rapid antigen test showed similar results to the most-accurate way to assess coronavirus infection — polymerase chain reaction (PCR) testing.

The QuickVue at-home test agreed with positive results of PCR testing 84.8% of the time and negative results 99.1% of the time, the company said in a release.

"Quidel's employees have truly risen to the challenge of the SARS pandemic," said  Douglas Bryant , president and CEO of Quidel Corporation. "Our mission is to provide greater access to frequent, affordable and highly accurate diagnostic testing, and ultimately to enable individuals to take charge of their own health and help them make prudent decisions to protect themselves and their loved ones."

"This is an important first step in a two-step process that, once additional ongoing studies are completed, will further expand access to frequent testing at home," Bryant added.

The FDA has now approved four at-home tests for emergency use authorization.

In November of last year, Lucira's at-home testing kit was the first of its kind to receive the emergency use authorization. Abbot Diagnostics' BinaxNOW test followed, along with Ellume's at-home testing option, according to the FDA.

(c)2021 Staten Island Advance, N.Y. Distributed by Tribune Content Agency, LLC.


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