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.
(TNS) — The
"The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic," said Dr.
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
"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.
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