The U.S. Food and Drug Administration has authorized the first diagnostic test that uses saliva collected at home.
The agency announced Friday it issued an emergency use authorization to Rutgers Clinical Genomics Laboratory, which developed a way to test saliva samples that were collected by patients at home.
Patients will collect their own samples and send to the Rutgers laboratory in a sealed package for testing.
The FDA described it as a “designated self-collection kit.”
“This provides an additional option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor’s office, hospital or testing site,” FDA Commissioner Stephen M. Hahn, M.D., said in a statement.
That test is currently the only authorized COVID-19 diagnostic test that uses saliva samples to test for SARS-CoV-2, the strain of coronavirus that causes COVID-19.
The FDA said it was important to note that “this is not a general authorization for at-home collection of patient samples using other collection methods, saliva collection devices, or tests, or for tests fully conducted at home.”
