At-home coronavirus tests currently do not have FDA approval

Posted at 9:05 PM, Mar 20, 2020

As many health officials say there is a shortage of available tests for coronavirus, the FDA is warning people about unauthorized test kits.

The FDA said that despite several companies beginning to offer at-home test kits, no at-home test kits have been approved by the agency, and the FDA is asking for the public to report unauthorized test kits to the agency.

"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 FDA said on Friday.

Friday's announcement by the FDA comes 11 days after the FDA said it sent a number of letters to businesses claiming to sell products that claim to prevent or cure coronavirus.

The FDA said that fraudulent health claims, tests, and products can pose serious health risks. The FDA added that the test kits could keep some patients from seeking care or delay necessary medical treatment.

“The FDA considers the sale and promotion of fraudulent COVID-19 products to be a threat to the public health. We have an aggressive surveillance program that routinely monitors online sources for health fraud products, especially during a significant public health issue such as this one,” said FDA Commissioner Stephen M. Hahn, M.D.

The FDA said it will take action to protect the public from bad actors who take advantage of a crisis to deceive the public. This may include issuing warning letters, seizures or injunction, the FDA said.

Although no at-home tests have been officially approved, some companies say they are releasing tests through an emergency use authorization.

An emergency use authorization stipulates that “the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.”