The FDA authorized its first COVID-19 diagnostic test that allows a person to collect a simple saliva sample themselves without leaving their homes, similar to a personal DNA test.
The green light expands upon a previous authorization for a test developed by Rutgers University designed to use a person’s spit instead of a nasal swab. The agency also granted its blessing to LabCorp’s at-home swab test in late April.
“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 FDA has authorized more than 80 COVID-19 tests and adding more options for at-home sample collection is an important advancement in diagnostic testing during this public health emergency,” Hahn added.
Rutgers’ prescription-only molecular test currently remains the only diagnostic authorized by the FDA to process saliva samples. After using a collection kit made by Spectrum DNA, the sealed package is then mailed to the New Jersey university’s clinical genomics lab for analysis.
Previously, the university said that quickly administered, saliva-based tests could find equally important use in the field—not just in the home—by sparing healthcare workers exposure from collection methods that require them to manually swab a person’s deep nasal cavity.
"Now imagine—you pull up, you roll down your window, they give you the collection device, it takes seconds to spit into it. You put the cap on, which releases the preservation solution into the vial," said Rupen Patel, CEO of Accurate Diagnostic Labs, which helped develop the test.
"You wipe it with a disposable alcohol pad, and you hand it back to the person at the window and you go off on your way,” Patel added. “Twenty-four to 48 hours later, you get your test results.”