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May 01, 2020 - Coronavirus (COVID-19), FDA, Emergency Use Authorization (EUA)

COVID-19 Update: FDA Authorizes First At-Home Collection Kit

Using Waivers to Curb COVID-19 Legal Exposure

FDA has been actively working to accelerate access to diagnostic tests for COVID-19 through its extension of Emergency Use Authorizations (EUAs). According to FDA Commissioner Stephen M. Hahn, M.D., “The FDA’s around-the-clock work since this outbreak began has resulted in the authorization of more than 50 diagnostic tests and engagement with over 350 test developers.”

Still, as we previously reported, no diagnostic test had been authorized for at-home collection by Americans. But that changed last Tuesday when FDA authorized the first diagnostic test with an at-home collection option for COVID-19. Specifically, the agency re-issued an EUA for the Laboratory Corporation of America’s (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home.

Importantly, the EUA is not a general authorization for at-home tests fully conducted at home. Instead, the EUA permits at-home collection using LabCorp’s designated self-collection kit, which contains nasal swabs and saline. Once patients self-swab to collect their nasal sample, they mail their sample, in an insulated package, to a LabCorp lab for testing. LabCorp intends to make these kits available to consumers in most states (with a doctor’s order) within the coming weeks.

FDA worked with LabCorp to ensure that at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital, or other testing site. FDA encourages developers to discuss their validation of home use or self-collection tests with the agency early in their development process.

To that end, while the LabCorp self-collection kit includes a specific nasal swab and may not be used with other cotton swabs at the present time, FDA is working with test developers to determine whether or not Q-tip-style cotton swabs can be used safely and effectively with other tests.

The Morrison & Foerster COVID-19 Task Force will continue to provide updates as FDA issues guidance for consumer-facing product manufacturers.