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The FDA Has Approved The First At-Home Rapid COVID-19 Test

Parents can get the test with a prescription, but it can't be used at home on young children.

Individuals looking to get tested for COVID-19 may no longer have to schedule appointments with a doctor or testing site. The U.S. Food and Drug Administration (FDA) approved the first rapid at-home COVID-19 test Tuesday, according to an announcement from the federal agency. But while the self-administered, at-home test may save some folks from having to visit a testing site, families with young children may still have to arrange point-of-care tests. The test approved by the FDA Tuesday can only be acquired with a prescription and can't be used at-home on children under the age of 14.

The Lucira COVID-19 All-In-One Test Kit is the first COVID-19 diagnostic test designed to provide rapid results when self-administered at home to be issued an emergency use authorization by the FDA. According to Lucira, the COVID-19 all-in-one kit is a single-use test that takes less than a minute to self administer and is designed to provide results in 30 minutes.

"While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home," FDA Commissioner Dr. Stephen M. Hahn said in a press release issued by the federal agency on Tuesday. "This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission. Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”

For instances of at-home use where the test is self-administered, the Lucira COVID-19 All-In-One Test Kit has been authorized for use in individuals age 14 and older who are suspected by a health care provider of having COVID-19 (the test must be prescribed by a doctor). While the test won't be available for at-home use with young children, it can be administered on children under the age of 14 if used in a point-of-care setting such as a doctor's office, hospital, urgent care facility, or emergency room, and the sample is collected by a health care provider rather than by the child or their parent. One single-use test kit is expected to cost around $50, Lucira noted in a recent press release.

Still, with just three, easy to complete steps — rotate the swab in each nostril five times, stir the swab into the sample vial, and insert the sample vial into the test unit — the test kit is a step toward providing real options for at-home testing and reducing test turnaround, things health care providers and experts have long been calling for, according to CBS News.

”Being able to quickly determine if a person is infected or not has been a global problem,” Dr. John Chou, a physician with the Palo Alto Foundation Medical Group who is also a principal investigator in the Lucira Health Community Testing Study, said in a statement provided by Lucira. “We believe this highly mobile test can make a big difference by providing lab-quality results expeditiously and conveniently. Early, accurate detection is vital to delivering appropriate care and controlling the pandemic.”

In a press release put out Tuesday, the FDA said it hoped its authorization of the test kit would ultimately help reduce the spread of COVID-19. "Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19," Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said. "Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them.”

If you think you’re showing symptoms of coronavirus, which include fever, shortness of breath, and cough, call your doctor before going to get tested. If you’re anxious about the virus’s spread in your community, visit the CDC for up-to-date information and resources, or seek out mental health support. You can find all of Romper’s parents + coronavirus coverage here.