FDA grants first emergency use authorization for a fully self-administered, at-home COVID-19 testing kit

Lucira Health nabbed the first emergency use authorization (EUA) for an at-home COVID-19 testing kit from the United States Food and Drug Administration (FDA) this week, opening up a new option for patients age 14 or older who health care providers suspect of having COVID-19.

The diagnostic is a single-use, all-in-one test kit capable of detecting SARS-CoV-2 — the virus that causes COVID-19 — in the body. It does so through the diagnosis of nasal swab samples, and beyond its novel at-home use, is also authorized for use in point of care settings for all ages. It can only be provided by prescription.

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

The molecular test can produce results within 30 minutes. A light-up display displayed whether a person has tested positive or negative for the SARS-CoV-2 virus. Additional care can then be sought from a health care provider for those who have tested positive — although those with symptoms but a negative diagnosis are not necessarily COVID-19 free, either.

All test results from these at-home tests will need to be given to health care providers to pass on to relevant public health authorities.

“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. “We look forward to proactively working with test developers to support the availability of more at-home test options.”