FDA Announces Authorization of First At-Home Coronavirus Test
The U.S. Food and Drug Administration has authorized the first at-home diagnostic COVID-19 test, according to a Tuesday media release.
The FDA re-issued the emergency use authorization for the Laboratory Corporation of America’s COVID-19 test so people at home can collect their own samples to be tested via LabCorp’s home collection kit, the FDA reported in the news release.
“Throughout this pandemic we have been facilitating test development to ensure patients access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options,” FDA Commissioner Stephen M. Hahn said.
According to the commissioner, the FDA has authorized over 50 diagnostic tests and engaged with over 350 test developers.
“Specifically, for tests that include home sample collection, we worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital or other testing site,” Hahn said.
“With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home.”
The Pixel by LabCorp COVID-19 self-collection kit includes a Q-tip-style cotton nasal swab and saline. The FDA does not recommend using your own cotton swab at this time.
After a nasal sample is collected, patients will mail the sample in an insulated package to an authorized LabCorp lab for testing.
The collection kits will hopefully be available to consumers with a doctor’s order in most states in the next few weeks.
At this time, the authorization only applies to nasal swab specimens gathered by using the Pixel by LabCorp COVID-19 home collection kit.
LabCorp was just one of many companies that tried to have their own COVID-19 tests authorized for at-home use, STAT News reported.
Some companies, including Nurx, Carbon Health and EverlyWell, reportedly thought their tests were in the clear and sold them directly to consumers but pulled their products after the FDA issued stern guidance about the at-home tests.
MicroGen DX and Vault Health even told STAT News that their saliva tests were cleared for at-home sample collection.
However, the FDA has administered warnings for consumers to be wary of “unauthorized fraudulent test kits.”
“Fraudulent health claims, tests, and products can pose serious health risks,” the FDA said in a statement.
“They may keep some patients from seeking care or delay necessary medical treatment.”
As of Tuesday morning, there were 788,920 cases of coronavirus in the United States, according to data from Johns Hopkins.
