FDA to Americans: Avoid At-Home COVID-19 Tests

The agency announced that it’s “aggressively monitoring” for fraudulent COVID-19 test kits, after many companies had thought their at-home tests were in compliance.

A staff member is working in a test station for COVID-19 in Munich, Germany. She is holding a sample tube with a nasal swab in her hand. | Getty Images
A staff member is working in a test station for COVID-19 in Munich, Germany. She is holding a sample tube with a nasal swab in her hand. | Getty Images

In light of the federal government’s slow response to the coronavirus pandemic and limited available tests, start-ups have been scrambling in recent weeks to develop at-home tests for people to order online. But after the Food and Drug Administration issued guidance late last week that it had not authorized any at-home tests, those companies were forced to scrap their plans. 

That guidance even thwarted shipments of at-home test kits that the start-up Nurx, which typically provides mail-ordered birth control, reportedly had planned for as recently as last weekend. Like other tests being developed for COVID-19, the at-home kits involved a sample taken by swabbing the nose or throat.

In the FDA’s statement published on March 20, it said that it “has not authorized” any at-home COVID-19 tests that consumers can purchase on their own. The agency added that fraudulent health claims or products “pose serious risk” and that it would send warning letters, injunctions, or seizures to any actors who don’t follow its guidance.

“The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers in this space,” the statement said.

While the the Centers for Disease Control and Prevention had been centrally responsible for testing in the U.S., the FDA issued an emergency use authorization in late February meant to allow labs to produce diagnostics, as cases in the U.S. have continued to spike. According to TechCrunch, some of these companies that entered the at-home COVID-19 testing business had been working with partner labs and thought they’d been in compliance with the FDA’s earlier order.

Companies including Nurx, Carbon Health, and Everywell had all been rapidly working to develop testing programs. Everlywell was profiled in a splashy, widely shared article on Time last week about its $135 test kits. (A visit to Everywell’s website on March 24 showed the kits are “not yet available” for individuals to purchase.)

Employees at these companies have said at-home testing poses an alternative for people who don’t need hospitalization or are at lower risk of severe symptoms from COVID-19.

The federal government has come under fire for lagging behind in testing at this stage of the pandemic compared to other countries. including China and South Korea. To make matters more complicated, prominent people such as NBA players and U.S. senators who are not exhibiting any symptoms have accessed testing in cities including New York, considered a new epicenter, whereas everyday people have not been able to. 

“It’s better than nothing, for sure,” Eric Topol, director of the Scripps Translational Science Institute, told the science publication STAT about the possibility of at-home testing. “But we’re two months late. It’s a small attempt to help a little bit. It’s not worthless, but it’s so little, so late, it’s embarrassing.”

The medical community, in the meantime, has been looking for quicker options to lab-test people who are asymptomatic in order to slow the outbreak, as there is no cure or existing vaccine. The FDA has authorized a 45-minute diagnostic test from Silicon Valley company Cepheid, and shipping to hospitals is expected to begin this week.

One team of researchers at Columbia University’s Mailman School of Public Health led by Ian Lipkin, one of the world’s leading infectious-disease epidemiologists, is working to quickly fund and scale production of a diagnostic test for COVID-19 as well.