4th at-home COVID-19 test gets emergency use authorization from FDA

FDA approves four at-home COVID-19 tests

The FDA gave approval for the QuickVue At-Home COVID-19 Test, allowing certain consumers to rapidly test themselves for the coronavirus.

WASHINGTON - The U.S. Food and Drug Administration has granted emergency use authorization for another COVID-19 at-home test.

The agency approved the Quidel QuickVue At-Home COVID-19 Test, allowing eligible consumers to rapidly test themselves for the coronavirus without having to send a sample to a laboratory for analysis.

Only health care providers can prescribe the nasal swab test for patients who suspect they may have the coronavirus within the first six days of experiencing symptoms.

Results can be delivered in as little as 10 minutes.

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

"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," Douglas Bryant, president and CEO of Quidel Corporation said in a statement.

"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 said.

To date, the FDA has approved four at-home tests and hundreds of tests that must be performed or analyzed by a health care provider or at a laboratory.

The agency approved the first prescription-only COVID-19 at-home rapid test in November for the single-use test kit from Lucira Health, a California test developer. The company’s test allows users to swab themselves to collect a nasal sample. The sample is then swirled in a vial of laboratory solution that plugs into a portable device. Results are displayed as lights labeled positive or negative.

The FDA approved the first non-prescription at-home COVID-19 test in December from Australian manufacturer Ellume. The kit includes a nasal swab, a chemical solution and a testing strip. The test connects digitally to a smart phone app that displays the results and then helps interpret them. Users can also connect with a health professional via the app.

Health officials are concerned that the plunge in overall COVID-19 testing may give Americans false hope that the pandemic is drawing to a close.

Just five weeks ago, Los Angeles County was conducting more than 350,000 weekly coronavirus tests, including at a massive drive-thru site at Dodger Stadium, as health workers raced to contain the worst COVID-19 hotspot in the U.S.

Now, county officials say testing has nearly collapsed. More than 180 government-supported sites are operating at only a third of their capacity.

U.S. testing hit a peak on Jan. 15, when the country was averaging more than 2 million tests per day. Since then, the average number of daily tests has fallen more than 28%. The drop mirrors declines across all major virus measures since January, including new cases, hospitalizations and deaths.

Officials say those encouraging trends, together with harsh winter weather, the end of the holiday travel season, pandemic fatigue and a growing focus on vaccinations are sapping interest in testing.

"When you combine all those together you see this decrease," said Dr. Richard Pescatore of the health department in Delaware, where daily testing has fallen more than 40% since the January peak. "People just aren’t going to go out to testing sites."

"We need to use testing to continue the downward trend," said Dr. Jonathan Quick of the Rockefeller Foundation, which has been advising Biden officials. "We need to have it there to catch surges from the variants."

The Associated Press contributed to this report. This story was reported from Los Angeles.