FDA Broadens Authorization of Rutgers' Saliva-Based COVID-19 Test

May 9, 2020

Testing will now be possible for those who cannot get to a collection center, including those who are home because they are ill, quarantined, or at high risk of infection due to their age or comorbidities. A Rutgers official said the new method will allow for a dramatic increase in the number of people who can be tested.

FDA on Friday expanded the authorization of the first diagnostic test for coronavirus disease 2019 (COVID-19) that uses saliva samples people collect at home. Statements from both the FDA and Rutgers say this expanded use will allow for more widespread testing and increase safety for both the public and health care professionals, who will be spared the need for invasive testing procedures on patients.

The emergency use authorization (EUA) was granted to Rutgers Clinical Genomics Laboratory for the COVID-19 laboratory developed test (LDT), which had already been authorized under the high complexity molecular-based LDT “umbrella” EUA, allowing self-collected saliva samples for use with the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device. Rutgers developed the test in partnership with Spectrum solutions and Accurate Diagnostic Labs.

According to a statement from FDA, this step “builds on last month’s EUA for the first diagnostic test with a home-collection option,” which used a sample obtained from a person’s nose with a swab and saline.

Rutgers officials said in a statement the new test method also avoids excess use of personal protective equipment (PPE).

“The impact of this approval means that not only do we no longer have to put health care professionals at risk for infection by performing nasopharyngeal or oropharyngeal collections, we can now preserve precious PPE for use in patient care instead of testing and can significantly increase the number of people collected each and every day in places other than a health care setting,” said Andrew Brooks, professor of genetics and chief operating officer and director of technology development at RUCDR.

Testing will now be possible for those who cannot get to a collection center, including those who are home because they are ill, quarantined, or at high risk of infection due to their age or comorbidities. Brooks said the new method will allow for a dramatic increase in the number of people who can be tested, “in a variety of locations.”

“Collecting a saliva sample at home mitigates the risk of exposure needed to travel to a facility or drive-through and is less invasive and more comfortable and reliable than sticking a swab up your nose or down your throat,” he said. “Protecting both patients and health care professionals from any unnecessary exposure is of paramount importance and saliva home collection addresses almost all issues around testing quality, safety and availability.”