The US Food and Drug Administration on Monday granted emergency use authorization to the Quidel QuickVue At-Home Covid-19 Test.
Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement that “The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic.”
Here are some key things to know about the at-home test:
- The test is authorized for at-home use once prescribed by a physician.
- The nasal swab test can be self-administered by people who are 14 years of age and older, or samples can be collected by an adult in children 8 years of age and older.
- The test is to be used within the first 6 days that someone is experiencing symptoms of Covid-19.
Rapid antigen tests have been shown to be less accurate than RT-PCR tests, which are considered the “gold-standard” of diagnostic testing.
In a press release, Quidel said the test can return results in as little as 10 minutes, and that positive test results match PCR tests 84.8% of the time; negative test results match PCR results 99.1% of the time.
The sample swabs are placed in a test tube along with a test strip. Colored lines on the test strip indicate a positive or negative test result, similar to a home pregnancy test.
In a separate news release Monday, the National Institutes of Health announced it is evaluating the use of Quidel’s QuickVue test with a smartphone app. The agency says it has enrolled more than 200 participants in the study, which requires them to use the test daily for two weeks.
The NIH says that as at-home tests become more widely available, it believes companion apps will play a role in tracking symptoms, administering tests and reporting results to public health authorities and health care providers.
“Understanding how individuals interact with these apps and where they find value in them will inform future efforts to advance at-home COVID-19 testing,” the NIH said in a statement.