March 24, 2020
With the shortage of diagnostic test kits for COVID-19 in the U.S., a handful of startups have created what they are calling at-home tests for the coronavirus, prompting the federal government to alert people that none of these self-administered tests have received approval yet.
"We want to alert the American public that, at this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19. 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 warning states.
The concern is that these unauthorized self-administered tests have the potential for false negatives and false positives which can affect patients getting the right care.
The FDA emphasized that Americans should follow the U.S. Centers for Disease Control and Prevention's guidelines and to call your healthcare provider if you have symptoms of COVID-19.
The agency also said it will issue warning letters, seizures or injunctions to companies marketing coronavirus at-home tests.
RapidDefend, a Delaware health protection company, is working with the FDA to launch its test, called Coronavirus Rapid Home Test Kit – Whole Blood, here in the U.S. Pre-orders for shipping to other countries, however, is currently available, with deliveries expected to start the week of April 13.
Chris Taylor, director of marketing, told PhillyVoice, "Given that the COVID-19 diagnostic tests guidance document issued on March 16, 2020, explicitly excludes at-home testing, we have requested the FDA to advise of next steps for us to obtain FDA Emergency Use Authorization approval so that our test kits can be provided to those who need it most. Once approved, our kits will be available to U.S. residents."
Misinterpretation of the Emergency Use Authorization revised guidelines aimed at expanding testing availability appears to be at the heart of the confusion between some companies and the government.
According to STATNews, startups like Nurx and Carbon Health contended their test kits did fall under Emergency Use Authorization because their labs have been certified under quality-control standards, a requirement of the emergency authorization.
Since then, both companies have taken the at-home test kits off their websites. Nurx in an update on its website says that it has halted new test requests, stating, "Given new guidance from the FDA on March 21, specific to self-collection laboratory testing, Nurx and our longstanding and trusted laboratory partner Molecular Testing Labs have made the responsible decision to pause on providing any additional self-collection COVID-19 tests."
Carbon Health's website, while no longer including the at-home test kits, still offers testing in its clinics and an online coronavirus assessment tool.
An FDA warning has also been issued to companies who sell teas, essential oils, tinctures and colloidal for the purpose of curing, treating or preventing COVID-19 and other serious diseases.