FDA Approves First At-Home COVID-19 Test Kit

The United States Food and Drug Administration has approved the first at-home kit that tests for COVID-19, the disease caused by the novel coronavirus. The device, known as the Lucira COVID-19 All-In-One Test Kit, provides results in under 30 minutes by testing a self-collected nasal swab sample. A light on the display indicates whether the result is positive or negative.

Previously, individuals had to visit a doctor’s office, hospital, or testing site to undergo a COVID-19 test. Alternatively, samples could be collected at home and mailed to a laboratory for analysis. The approval of this at-home kit is crucial as it is expected to facilitate wider testing across the country, making it more accessible for everyone.

“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 M. Hahn stated. This novel testing option represents an important diagnostic advancement aimed at addressing the pandemic and reducing the public burden of disease transmission. The single-use kit is currently prescribed only for individuals aged 14 and older whose healthcare provider suspects they have COVID-19. Younger patients can still undergo testing at a doctor’s office or hospital.

“Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “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.”

Experts generally believe that this type of test may be less accurate than PCR testing, which is typically required for travelers heading to numerous popular tourist destinations. However, it produces results more swiftly. Lucira has reported that its test accurately detected 94% of infections and 98% of healthy individuals, although the study was small and only included those with COVID-19 symptoms. It is anticipated that the test will be priced around $50 and will be available from healthcare providers across the country by spring.