Nov. 18, 2020 -- The FDA issued an emergency use authorization Tuesday for the first self-testing COVID-19 kit to use at home, which provides results in about 30 minutes.
The Lucira COVID-19 All-In-One Test-Kit is a single-use test that has a nasal swab to collect samples for people ages 14 and older. It’s available only by prescription, which can be given by a doctor who suspects a patient may have contracted the coronavirus.
“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 Stephen Hahn, MD, said in the statement.
The test kit can also be used in doctor’s offices, hospitals, urgent care centers, and emergency rooms for all ages, but samples must be collected by a health care professional if the patient is under age 14.
After using the nasal swab, the test works by swirling the sample in a vial and then placing it in the provided test unit, according to the FDA. Within 30 minutes, the results appear on the unit’s light-up display. People who receive a positive result should self-isolate and seek care from their doctor. Those who test negative but have COVID-like symptoms should follow up with their doctor, since a negative result doesn’t necessarily mean they don’t have the coronavirus.
Testing is still a key part of controlling the spread of the coronavirus, Reuters reports. The U.S. surpassed 11 million infections Sunday, only 8 days after passing 10 million cases.
With the at-home testing kit, public health officials still need to track and monitor results. As part of the emergency use authorization, the FDA requires doctors who prescribe the tests to report all results to public health authorities based on local, state, and federal requirements. Lucira Health, the test maker, also created box labeling and instructions to help doctors to report results.
“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,” Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in the statement.