The FDA issued its first authorization of an at-home saliva test for COVID-19 on Friday, which will allow patients to receive a diagnostic test without leaving the home.
The Emergency Use Authorization was issued to Rutgers Clinical Genomics Laboratory for its Spectrum Solutions LLC SDNA-1000 Saliva Collection Device.
The FDA says the test permits testing of a saliva sample collected from the patient using a designated self-collection kit. Once patients collect their saliva sample, they return it to the lab in a sealed package for testing, the FDA added.
The test is by prescription only.
The test was previously given an emergency use authorization, but could not be administered at home until now.
“Authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19. 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 Stephen M. Hahn, M.D. “We will continue to work around the clock to support the development of accurate and reliable tests, as we have done throughout this pandemic. 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.”
The benefit of the Rutgers test is that it does not require a swab to be used, which has seen a shortage during the ramp up of testing.
“Saliva testing will help with the global shortage of swabs for sampling and increase testing of patients, and it will not require health care professionals to be put at risk to collect samples,” said Andrew Brooks, a technology development expert and professor at Rutgers. “Saliva testing will also be important for people who are in quarantine because they don’t know how long it will be until they are no longer infectious. This will allow health care workers to release themselves from quarantine and safely come back to work.”