WASHINGTON, May 9, 2020 (BSS/AFP) – The US Food and Drug Administration (FDA) on Friday approved the first diagnostic test for coronavirus using saliva samples collected at home.
The test, which was granted an emergency use authorization by the FDA, was developed by Rutgers Clinical Genomics Laboratory.
The agency last month approved a COVID-19 diagnostic test with a home-collection option using samples taken from a patient’s nose with a swab.
“Authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19,” FDA commissioner Stephen Hahn said in a statement.
“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.”
The Rutgers test is by prescription only for the moment.
A patient collects a saliva sample using the self-collection kit and sends it for testing to the Rutgers lab, currently the only site that uses saliva samples to test for SARS-CoV-2, the coronavirus that causes COVID-19, the FDA said.
The FDA has authorized more than 80 COVID-19 tests, most of which are performed by private laboratories or research facilities.
“Adding more options for at-home sample collection is an important advancement in diagnostic testing during this public health emergency,” Hahn said.
On April 20, the FDA authorized one of the largest private US laboratory chains, LabCorp, to analyze nasal samples collected by patients at home.