Rutgers' saliva-based test nets FDA green light for COVID-19

Clinical genomics researchers at Rutgers University have received the FDA’s first emergency authorization for a COVID-19 diagnostic test that uses easy-to-collect saliva samples instead of the more difficult deep nose swabs.

This method could allow broader population screening for active coronavirus infections—however, the FDA’s green light only covers the prescription-only test’s use at the university’s New Jersey lab for the time being.

“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, chief operating officer and director of the university’s cell and DNA biorepository, known as RUCDR Infinite Biologics. 

“We can preserve precious personal protective equipment for use in patient care instead of testing,” Brooks said, describing how the swab method requires a clinician to stand in close proximity to the patient, potentially exposing them to exhaled droplets and the virus.

“We can significantly increase the number of people tested each and every day as self-collection of saliva is more quick and scalable than swab collections,” he said. “All of this combined will have a tremendous impact on testing in New Jersey and across the United States.”

Developed in collaboration with Accurate Diagnostic Labs and utilizing Spectrum DNA’s spit collection and preservation kits, the researchers were able to show their saliva-based test performed just as well as as the potentially painful swabs when searching for the specific RNA sequences linked to the novel coronavirus. 

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Built off a previously authorized COVID-19 test developed by Thermo Fisher, Rutgers’ assay uses the same PCR hardware and chemical components as the company’s TaqPath kit. Saliva specimens must be stored or transported at ambient temperatures, and tested within 48 hours of collection, according to the researchers.

"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. 

"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 said. “Twenty-four to 48 hours later, you get your test results.”

Following the FDA’s authorization, Brooks said the researchers had been contacted by the White House and the federal government’s pandemic response team as well as by large life science companies involved in COVID-19 testing.

“I have spoken with these companies’ leadership to not only share knowledge but to create opportunities for continuing to help innovate during this crisis,” said Brooks. “We will work closely with these new partners, the FDA and the White House task force to leverage everything Rutgers has to offer to not only help our community but also make a global impact.”

RUCDR recently launched its own genetic testing service for COVID-19 focused on nasal samples, but it hopes the saliva test will be able to increase the number of tests it processes per day.

The spit tests will be available through the RWJBarnabas Health network, including Robert Wood Johnson University Hospital, University Hospital in Newark and other New Jersey facilities and county health departments. The health system and Rutgers also plan to begin offering drive-thru testing in Middlesex County this week.