Below is what you need to know about the at-home test.
How can I get a Quidel QuickVue COVID test?
The Quidel QuickVue at-home COVID test is now available with a prescription, meaning people in the U.S. can get one from their health care provider.
Doctors can prescribe the QuickVue test if they suspect their patient has COVID-19 within the first six days of symptom onset.
How much does it cost?
Neither the FDA nor Quidel said how much each test would cost in their EUA press releases. Newsweek has contacted the FDA and Quidel for information.
How does the test work?
QuickVue is a lateral flow test—a type of COVID test that is more portable and typically returns results faster than the widely used laboratory-based PCR tests.
It works by testing nasal swab samples and provides a positive or negative result within 10 minutes. The result shows up on a test strip that has been exposed to the nasal swab sample.
Swabs can be collected from people aged eight and above, though swabs should be collected by an adult if the child being tested is younger than 14 years old, the FDA said.
How accurate is the test?
Quidel claimed the test produces positive results that match up with a PCR test 84.8 percent of the time, and negative results that match up with a PCR test 99.1 percent of the time.
The FDA said a negative test result from the QuickVue test does not necessarily rule out a COVID-19 infection and “should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.
“Persons who test negative and continue to experience COVID-19 like symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow up care with their physician or healthcare provider.”
Not all lateral flow tests require a prescription to be used. On December 15, the FDA issued an EUA for the first over-the-counter at-home lateral flow COVID test.
The Ellume COVID-19 Home Test also uses a nasal swab sample to detect a COVID infection, and works on people aged two and above.
The FDA said the Ellume test correctly identified 96 percent of positive samples and 100 percent of negative samples in people with COVID symptoms. In those without symptoms, it picked up 91 percent of positive samples, and 96 percent of negative samples.
Similarly, the FDA said negative results using that test do not necessarily rule out a COVID infection.
The wider picture
A total of 28.4 million COVID cases had been reported in the U.S. as of Monday, and 511,839 deaths, according the CDC.
Data also showed there were 50,505 new cases on Monday, 1,062 new deaths, and 76.9 million people had been administered a vaccine.
