First At-Home Rapid COVID-19 Test Gets Green Light

(RxWiki News) The US Food and Drug Administration (FDA) has approved the first COVID-19 test that can be administered and give results at home. And the results can come in less than half an hour.

FDA officials said this new test represents an important step in ongoing efforts to fight the COVID-19 pandemic in the United States.

“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,” said FDA Commissioner Dr. Stephen M. Hahn in a press release. “This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.”

The FDA gave emergency use authorization (EUA) to the Lucira COVID-19 All-In-One Test Kit for at-home use in people who are 14 years old or older. The test is administered via a nasal swab that the user then swirls in a vial and places in the test unit. Results come in 30 minutes or less, according to the FDA.

This test is only available by prescription, and health care providers who prescribe it are required to report all results to ensure accurate tracking, the FDA noted.

A positive result indicates that the virus that causes COVID-19 infection is present. If you receive a positive result, you should self-isolate and reach out to your health care provider for further instructions. If you are experiencing symptoms that are associated with COVID-19 but your test is negative, still notify your health care provider.

According to the FDA, you can still be infected with COVID-19 if you receive negative test results. But the test did appear to be highly accurate. In one comparison of the results of this new test to the results of a highly accurate test that was previously approved, the new test was accurate 94 percent of the time when it gave a positive result and 98 percent of the time when it gave a negative result, according to the maker of the test.

The FDA also approved the Lucira COVID-19 All-In-One Test Kit to be used in emergency rooms, hospitals, doctors’ offices and urgent care centers with patients of any age.

If you are concerned that you might have COVID-19, seek immediate medical advice.