An At-Home Saliva Test for COVID-19

FDA approves first COVID-19 test that uses at-home saliva sample collection

(RxWiki News) Testing for COVID-19 has always involved nose or throat swabs — until now.

That's because the US Food and Drug Administration (FDA) has approved the first COVID-19 saliva test for at-home use.

With this recently approved test, people do not have to go to the hospital, a doctor’s office or a testing center to get tested. Instead, they can collect their own saliva at home and send their saliva samples in for testing.

Rutgers University's RUCDR Infinite Biologics lab received approval for this test through the FDA's emergency use authorization (EUA). That means this test is not authorized for use through regular FDA approval.

The lab noted that the test includes instructions on how to accurately collect the saliva sample. The samples are to be sent to the Rutgers Clinical Genomics Laboratory in a sealed package for testing.

Users must use the lab’s designated self-collection kit. This does not mean consumers can start collecting saliva using other methods that are not approved, the FDA noted.

Currently, the Rutgers Clinical Genomics Laboratory test is the only test that uses saliva to detect the virus, the FDA noted. This test requires a prescription.

Another at-home test (prescription only) was approved last month. This test, made by LabCorp, requires patients to collect samples by swabbing their nose. The samples are then sent to the lab for testing.

The FDA has authorized over 80 COVID-19 tests, including those that allow for at-home sample collection, in order to increase patient access to testing, the agency said.

“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,” said FDA Commissioner Dr. Stephen M. Hahn in a press release. “We will continue to work around the clock to support the development of accurate and reliable tests, as we have done throughout this pandemic.”

Speak with your health care provider if you have any questions.