The FDA has approved the first at-home COVID-19 test offering rapid results, one that is only available via prescription. The test is designed for use with individuals 14 years or older who potentially have been exposed to the virus, eliminating the need to visit a hospital or doctor’s office in person. The approval was given for the test via an Emergency Use Authorization.
Diagnostic tests are an important part of tracking and limiting the spread of SARS-CoV-2, the coronavirus that causes COVID-19. Despite this, the US has struggled with widespread testing — potentially infected people in the first few months of the pandemic reported an inability to get tested, for example.
Though testing has become more commonly available, many still avoid it out of fear of visiting a testing site and potentially contracting the virus there. An at-home testing kit removes that concern and makes it easier for doctors to have their patients tested without requiring them to leave isolation.
The testing kit is only available by prescription order and the FDA says that doctors who prescribe it are required to report the results for tracking purposes. According to the agency, test kit manufacturer Lucira Health includes quick-reference instructions, among other things, for at-home testers. Results are available at home within 30 minutes.
The FDA’s director of Center for Devices and Radiological Health Jeff Shuren said:
Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19. A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic. 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.