You can test yourself for COVID and get rapid results at home for first time, FDA says
Americans over 14 years old with a prescription from their health care provider can conduct their own COVID-19 nasal swab test and receive results within 30 minutes at home for the first time, officials say.
The U.S. Food and Drug Administration issued an emergency use authorization for the “Lucira COVID-19 All-In-One Test Kit” on Tuesday, paving the way for faster testing and contact tracing to help curb coronavirus spread.
The test was also approved for use in doctor’s offices, hospitals, urgent care centers and emergency rooms, the FDA said in a statement. Patients under 14 years old must be tested by a health care professional.
“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 Hahn, said in the statement. “This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.”
The test works similarly to rapid diagnostic tests conducted by professionals. Individuals must swivel a swab in each nostril for a certain amount of time then place the sample in the test unit. In 30 minutes or less, the results will appear on the unit’s display, the FDA says.
People who receive a positive test result should isolate themselves and seek additional care if needed, while those who receive a negative result but still feel COVID-19 symptoms should follow up with their primary care physician, “as negative results do not preclude an individual from SARS-CoV-2 infection,” according to the FDA.
Just like all other diagnostic COVID-19 tests, the new rapid at-home test requires individuals to contact a health care provider with their results so they can report it to local, state and/or federal health authorities, according to the FDA. Instructions will be provided on the test’s box to complete this process.
“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,” Dr. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in the statement.
There are more than 11.3 million confirmed coronavirus cases in the U.S. and nearly 249,000 deaths as of Nov. 18, according to Johns Hopkins. Worldwide, more than 55.7 million people have been infected with SARS-CoV-2 and more than 1.3 million people have died.
This story was originally published November 18, 2020 at 7:40 AM with the headline "You can test yourself for COVID and get rapid results at home for first time, FDA says."
