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Friday, April 9th, 2021

FDA authorizes Quidel QuickVue At-Home COVID-19 Test for emergency use

© Quidel Corporation

The U.S. Food and Drug Administration (FDA) granted emergency use authorization Monday for the Quidel QuickVue At-Home COVID-19 Test.

An antigen test, QuickVue will allow users suspected of having COVID-19 by their healthcare provider within the first six days of symptom onset to quickly collect and test their sample from the ease of their own homes. Anyone ages 14 and older can use it with a prescription, but the authorization also allows adults to use collection swabs on individuals 8 years old and up.

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

At the same time, the National Institutes of Health (NIH) announced that they will begin assessing the performance and usability of the smartphone app paired with the new at-home test. MyDataHelps offers a list of instructions for taking the test, along with tools such as timers to help ensure its various steps are completed in the proper time frame. The app also provides independent confirmation of test results if a user photographs the test strip with a smartphone.

More than 200 volunteers are currently enrolled in the study, which will involve daily testing over a two-week period. Researchers hope to use the study to better understand how individuals actually interact with such apps and where they derive the most value from therein.

Ultimately, the test should be capable of providing results within 10 minutes. Supported by NIH originally through the Rapid Acceleration of Diagnostics (RADx) program, Quidel eventually intends to apply for another emergency use authorization to allow the sale of the test over the counter without a prescription.